Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Responsibilities Acts as legal advisor for at least one key and/or a combination of Global Corporate Functions (examples listed below but may include others) that encompasses all areas of the business of Daiichi Sankyo in the U.S. and globally as assigned. [Specific assignment to be determined by direct manager of the role.<ul><li>Global Human Resources (including Benefits) Acts as the legal advisor for Human Resources groups within DSI and global legal entities, managing other internal and external legal counsel providing services in this area. Analyzes, applies and provides legal advice and counsel. Provides legal advice on employment law areas such as FMLA, ADA, FLSA, ADEA, employee privacy, state laws on wrongful discharge, wage and hour claims, contingent worker issues, diversity initiatives and workplace environment issues. Supports internal investigation, drafts employment separation agreements and provides guidance on restructurings, employee relations as well as compensation and benefits plans. Develops contract templates, reviews agreements, and manages outside counsel as necessary.</li></ul><ul><li>Global Corporate Communications Acts as legal advisor for Corporate Communications groups within DSI and global entities, providing legal advice on media relations, internal communications, public disclosures, social media policies, compliance, crisis communications, and diversity initiatives. Develops contract templates, reviews agreements, and manages outside counsel as necessary.</li></ul><ul><li>Global Government Affairs Acts as legal advisor for Government Affairs groups within DSI and global entities, advising on legislative and regulatory compliance, lobbying activities, political contributions, public policy development, and state and federal compliance. Develops contract templates, reviews agreements, and manages outside counsel as necessary.</li></ul><ul><li>Global Finance Acts as legal advisor for Global Finance groups, supporting Oncology Business Unit, Research and Development Unit, and other functions. Advises on issues related to financial transactions, procurement, financial operations, securities, tax, financial audits, real estate, and facility management. Develops contract templates, reviews agreements, and manages outside counsel as necessary.</li></ul><ul><li>IT/DX Acts as legal advisor for Global Information Technology/DX, providing legal advice, preparing legal documents, negotiating contracts, assessing security and technical provisions. Advises on issues related to data privacy, data management and Artificial Intelligence. Develops contract templates, reviews agreements, and manages outside counsel as necessary.</li></ul><ul><li>Global Compliance Acts as legal advisor for the Compliance function within DSI and other global legal entities, providing legal advice and support tailored to pharmaceutical compliance. Provides legal support for maintaining an effective compliance program, including legal review and support for policies, training, monitoring, and auditing projects. Ensures adherence to pharmaceutical industry regulations. Develops contract templates, reviews agreements, and manages outside counsel as necessary.</li></ul><ul><li>Global Business Development Acts as legal advisor for Business Development, handling legal aspects of licensing, co-promotion/co-development, strategic/financial investments, companion diagnostic, academic research organization, and acquisition deals. Advises senior management on legal and regulatory issues, leads complex transactions, and supports other agreements. Develops contract templates, reviews agreements, and manages outside counsel as necessary.</li></ul>Other Corporate Functions or areas, as assigned.<ul><li>Leads or participate as legal support for cross-functional project management teams set up to address mid-sized to large Company-driven initiatives or special projects relevant to assigned Corporate Functions. Projects may be internal to the Company as well as project involving external business partners and/or other entities. The result of such initiatives may include creating corporate-level policies, guidance documents (i.e. standing legal risk analyses), and training of Company employees, as well as implementation of systems or processes.</li><li>Monitors current developments in assigned key legal areas and provides Senior Management and other business leaders with updates regarding same (including Legal Affairs Department colleagues). Works independently and, as appropriate, in collaboration with other departments in developing, implementing and presenting training materials on various legal issues pertaining to assigned business areas. Such training materials may be presented to functions supported by this position (or by them) but would also be available for use by the Legal Affairs Department generally.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree required</li><li>JD from law school of recognized standing, and Bar admission required</li></ul>Experience Qualifications<ul><li>7 or More Years post-law school experience required</li><li>4 or More Years pharmaceutical industry experience, particularly supporting specific assigned business areas in contracting, general legal advice, policy development and/or review, etc. in specific business support functions (e.g., HR, IT, Compliance Program, etc.) in an in-house capacity, as a legal consultant, and/or at a law firm in a practice group focusing on pharmaceutical industry and/or specific corporate business functions; 7+ years preferred required Licenses and Certifications</li><li>Eligible to practice law in the state of New Jersey (either licensed in NJ or limited in-house license) and maintain such license in good standing at all times. required TravelAbility to travel up to 5% Occasional travel</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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Assistant General Counsel, Corporate Functions

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and statistical aspects for safety signal detection and characterization for ongoing studies and compound level pooled clinical trial data of project(s). Act as statistical expert consultant within company for safety analyses. Responsibilities:<ul><li>Lead for safety signal statistical handling, lead the statistical support in safety signal detection, validation, characterization and reporting in collaboration with safety programming team, CSPV, and epidemiology for several projects with minimal direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety signal monitoring for ongoing trials.</li><li>Safety analysis methodology and standardization, develop and support statistical safety analysis methodology and standardization across the clinical development in cross functional teams.</li><li>Builds partnership with safety programming teams, project statistical teams, and internal cross functional teams and external institutions to maximize available resources.</li><li>Safety working groups and initiatives, represent statistics to participate (and lead if applicable) in safety signal working groups or cross function initiatives.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>PhD In statistics or Biostatistics required</li></ul>Experience:<ul><li>Minimum 5 years of relevant experience in the pharmaceutical industry and experiences as a safety statistician required.</li></ul>Travel: <ul><li>10%</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $168,000.00 - $252,000.00 Download Our Benefits Summary PDF

Associate Director - Safety Statistician, Statistical Strategy and Innovation

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities: <ul><li>Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)</li><li>Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation; Oversees recruitment and retention; establishes and implements contingency plans for shortfalls; Consults & recruits members for DSMB and/or adjudication committee setup</li><li>Study outputs: Draft responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead e.g. review Tables/Listings/Graphs before database lock and quality check of data; Works with BD&O to ensure SAP update</li><li>External collaboration: Consults with internal experts and external KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes effective communication between CRO / vendors / ARO</li><li>Additional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares material for KOL interactions on a program based need; Involvement with in-licensing and acquisitions on individual due diligence activities</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university):<ul><li>Master's Degree or equivalent preferred or</li><li>PharmD or equivalent preferred or</li><li>PhD or equivalent preferred</li><li>Postgraduate training in TA or related specialty, or equivalent preferred</li></ul>Experience Qualifications:<ul><li>4 or More Years with PharmD, PhD and relevant clinical experience preferred</li><li>7 or More Years with Master's degree and relevant clinical experience preferred</li></ul>Travel: Ability to travel up to 30% In-house office position that may require travel (global). Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director Clinical Science

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Associate Director FP&A position is an integral part of the finance team supporting our applicable business partners and is responsible for providing financial leadership & guidance to achieve company objectives. This position will need to have a collaborative and teamwork mindset to bring value to our business partners and organization. The AD FP&A will lead the Annual Financial Plan, Quarterly LE Forecast, & monthly reporting processes for assigned areas. This role will also participate on the Alliance partnership fostering a strong business relationship and providing strategic financial guidance in meeting Alliance deliverables. This position will be responsible for finding novel approaches to solving problems and focus on improving processes across the organization. The person will be required to demonstrate strong interpersonal skills to build and manage effective working relationships throughout the organization. Responsibilities<ul><li>Business Partnering: Develops effective working relationships with business partners and influences strategic decisions to align to company objectives. Develops strong business knowledge of the Functions to help find synergies efficiencies across the organization. Challenges the status quo in an appropriate way to find more optimal and cost-effective approaches that are aligned to our strategy.</li><li>Financial Plan Latest Estimates (LEs): Leads the Annual Financial Plan LE Forecast cycles. Collaborates with business partners to monitor revenue expense performance indicators to provide guidance and insight into the financial forecasts. Develops proposals to mitigate / enhance risks and opportunities with sufficient lead time.</li><li>Management Reporting: Prepares monthly reporting package working with business partners on reasons for any variances and implications on business performance. Works with Director of FPA to streamline and improve reporting to offer management insights to make more informed business decisions. Develops KPI metrics and other tools to evaluate performance across the business.</li><li>Alliance Management: Develops a strong working relationship within the alliance. Drives the alliance forecasting process in partnership with internal and external teams. Provides guidance on the alliance forecasts as well as Actuals reporting and analysis while ensuring compliance with alliance policies and procedures. Act as Alliance Committee Finance Liaison providing guidance on financial matters to the commercialization teams.</li><li>Change Management Special Projects: Responsible for developing improving processes to enhance efficiencies, as well as offering novel solutions perspectives aligned with company goals. Accountable for any ad hoc special projects as they arise.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree in Accounting, Finance, or related field required</li><li>MBA in Finance preferred Experience Qualifications</li></ul><ul><li>7 or More Years experience in accounting and/or Financial Planning and Analysis-related work, and/or pharmaceutical/R&D experience required Licenses and Certifications</li><li>Certified Public Accountant (CPA) preferred</li></ul>Travel Ability to travel up to 10% potential limited travel for accounting conferences/trainings, etc. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Financial Planning & Analysis-1

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. Responsibilities - Support GMA the development of the Global Medical Affairs strategy and execution of the Global Medical Affairs plan for select indications/projects related to evidence generation, medical information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing budgets and resources for the assigned GMA plan activities, in collaboration with Sr Director. - Support medical readiness activities for market launches and life cycle management for select indications/projects. Gains strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide medical support/input into commercial and market access discussions for select indications. - Support as medical lead for select company-sponsored GMA evidence generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders. - Provides support in review of investigator-initiated studies (IIS) and may serve as deputy compound lead in Global IIS Review Committee meetings. - Leads selecting medical education and other scientific exchange activities in alignment with the Senior Director, such as scientific symposium and medical congresses, within legal and compliance regulations. - Collaborates across functions to support GMA MIE activities in order to achieve approval of key scientific communications resources such as medical information response documents, (non-) promotional materials, educational slide deck and other internal training resources, within legal and compliance regulations. Provide training or communication of emerging data (internal or competitive), such as congress updates and development program highlights. - Provides medical leadership in interactions with key external stakeholders and lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound. - Provides support in the review of GMA Publications (abstracts, presentations, and manuscripts) and may serve as deputy compound lead on the Publication Planning Subteam (PPS). Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - PharmD, PhD or MD preferred - Bachelor's Degree required - Master's Degree Advanced knowledge in medical/scientific area (Oncology) preferred Experience Qualifications - 4 or More Years overall relevant experience preferred - 4 or More Years experience in pharma at local, regional and/or Global level. preferred - Excellent knowledge of current clinical practice in Oncology / Hematology / Endocrinology or other relevant disease area preferred - knowledge in and understanding of medical activities (including scientific communications, medical information, MSLs, and HEOR), relating to the commercialization of oncology products preferred Travel Ability to travel up to 20% Standard office based physical demands, travel as required. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $168,000.00 - $252,000.00 Download Our Benefits Summary PDF

Associate Director, GMA Oncology

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Associate Director, Global Medical Affairs Oncology Publications works with GMA Oncology Publications Lead, to develop publication plans, drive the execution of publication projects, and support other GMA Oncology activities as needed for their assigned product. Responsibilities - Collaborate with alliance partners, Global and Regional Medical Affairs and various cross functional teams to develop and execute publication plans of assigned GMA Oncology product - Facilitate Publication discussions - Liaise with internal external authors, academic research organizations, and study investigators - Manage vendor budget and activities - Oversee the quality and timeline of vendor work - Collaborate with study clinical or medical lead and biostats to ensure availability of necessary data - Coordinate author review/approval internal review approval - Abstract/manuscript submission with vendor support - Facilitate response to journal reviewer comments/requests - Publication tracking and announcement, in coordination with Medical Information Education (ME) - Leads the planning, execution and delivery of publication projects to ensure high quality and timely delivery of scientific publications - Manage publication activities in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author approvals - Ensure documentation of compliance with authorship and publication guidelines as stipulated by the International Committee of Medical Journal Editors (ICMJE) and Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP) - Work with and oversee publication vendors to ensure deliverables are of high quality, delivered in a timely manner, and in budget. (Applicable for Oncology Medical Affairs) - Liaise with internal and external stakeholders, including authors, researchers, investigators, GMA Therapy Area leads, RD clinical leads, biostatistics and Joint Publications Team members on publication activities - Lead study publication committee discussions, including monthly, quarterly and yearly publication update meetings as neededoManage timelines of publication outputoFacilitate Publication discussionsoLiaise with internal external authors, academic research organizations, and study investigatorsoManage vendor budget and activitiesoOversee the quality and timeline of vendor workoCollaborate with study clinical or medical lead and biostats to ensure availability of necessary dataoCoordinate author review/approval internal review approvaloAbstract/manuscript submission with vendor supportoFacilitate response to journal reviewer comments/requestsoPublication tracking and announcement, in coordination with Medical Information Education (ME) - Support global medical communication plan development by collaborating with GMA team - Support other global data dissemination activities as neededSupport GMA Oncology Publications Lead by assisting with key meetings, acts as delegate - Align with the GMA Oncology Publications Lead and respective team members to ensure robust publication plans for the Therapeutic Area and respective products. - Lead and facilitate Joint Publication Team discussions as needed. Coordinate author review/approval and internal review approval of manuscripts, abstracts, poster presentations, oral presentations, medical slide deck and other ME materials related to the brand(s). - Manage vendor budget and activities and oversee the quality and timeline of vendor work. Manage Publication tracking and announcement, in coordination with Global Oncology Medical Affairs Team (GMAT) Lead and Medical Information Education or Global Specialty Medical Affairs (GSMA) Team. Contribute to development of publication plan budget. Collaborate with GMAT Lead on tracking and management of budget. Work with and oversee publication vendors to ensure deliverables are of high quality, delivered in a timely manner, and in budget. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree preferably in Health Sciences required - Other advanced degree preferably in Health Sciences preferred or - PharmD or PhD in Health Sciences preferred or Experience Qualifications - 7 or More Years overall related experience or commensurate education/experience required - Experience with publication planning required - 7 or More Years with publication/communication agency for MS degree in health sciences preferred - 4 or More Years of pharmaceutical industry, clinical, and/or academic experience for PharmD, or PhD preferred - 4 or More Years of pharmaceutical industry experience preferred - Proven track record of working successfully with cross-functional teams to achieve goals preferred - Experience with clinical trials and international work experience preferred Travel Ability to travel up to 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $159,440.00 - $239,160.00 Download Our Benefits Summary PDF

Associate Director, GMA Oncology Publications

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: This position oversees ICSR Standards activities, projects, and procedures. This level interacts within global CSPV and with CROs, vendors, and partners; and participates on interdepartmental study teams. This level handles escalated global CSPV case processing issue and handles project. This position prepares trainings, supports CAPA investigations, case review, documentation reviews in collaboration with the ICSR management and CRO/Vendor oversight groups for case processing activities and reports to the Director of PV Case Management. Responsibilities:<ul><li>ICSR Processing: Oversees QC activities, supports projects and interacts with the DSI Case Management team / global case management team and partners on a daily and as-needed basis. Management of escalated case processing issues/troubleshooting. Supports CAPA investigations / implementation.</li><li>ICSR Standards Oversight: Acts as subject matter expert in ICSR standards, decision making and trouble shooting. Identifies CRO/vendor training as needed. Reviews overall processes and identifies areas of concern, arranges for remediation. Performs review of data entry convention documents, PVA reviews and SAE flow plan / data management plan reviews. Works with ICSR management and CRO/Vendor oversight to manage relationship with CROs and Vendors.</li><li>Case Processing Policies and Procedures: Reviews, approves, provides input on and authors SOPS, SOIs, and process guides. Participates in inspection preparation activities and internal and external audits and audits CAPA preparation.</li><li>Case Processing Training: Identifies case processing and related CRO/vendor training needs and reviews case processing project specific training materials. Manages and coaches the PV Vendor Training Coordinator.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education: <ul><li>Bachelor's degree in nursing, pharmacy, life sciences, health care or related field; required</li><li>PharmD preferred</li><li>Master's Degree Life Sciences preferred Experience Qualifications</li></ul>Experience:<ul><li>4 or more years of experience in management experience in PV; required</li><li>10 or more years of experience within Drug Safety/Pharmacovigilance experience, including both investigational and marketed products; preferred</li><li>Extensive knowledge of AE and drug coding conventions (MedDRA, WHO-DD). preferred</li><li>Extensive knowledge of FDA regulations, clinical and safety databases, preferred</li><li>Familiarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP) preferred</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $150,800.00 - $226,200.00 Download Our Benefits Summary PDF

Associate Director, PV Case Management - ICSR

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The purpose of this job is to provide statistical programming technical support related to R programming, R related system and technology. Develop and drive R programming, package, and R shiny app development. Lead the R programming implementations. Represent programming in DS external collaborations on R technology and capabilities. Responsibilities: - Lead/contribute to DS R programming system technology development: Lead/contribute to the R programming system development. Act as R programming SME and functional representative of R systems and infrastructure to identify system and technology development needs and to define functional requirements. Provide technical guidance to the development. Lead and may approve UATs. Lead/contribute to resolutions of BDM departmental (internal and external) R related analysis and programming technical issues and difficulties. Lead the trainings and implementations of R system and programming technology. - Developing R package and Shiny apps: Contribute to strategy of R programming innovation to support BDM analysis and reporting, such as R shiny apps for data surveillance, visualization, modeling and simulations, and safety signal detection. Lead the development and validations of R package and/or shiny apps. Identify and build the use cases and process/resources to guide the implementations. Lead, advocate and nurture R programming innovation globally within DS. Represent the programming innovation outside of DS and establish the company reputations and images. - Develop study specific shiny apps or execute shiny apps at study level. Publish shiny apps for study or against integrated database - Representing cross-functional collaborations on R capabilities and systems: Collaborate with RD non-BDM and non-RD R user group or developers. Collaborate with biostat innovation to enhance BDM overall R capabilities and implementations. Collaborate with CSPV to enable/effectively support safety signaling detections and across compounds safety reviews (i.e., ILD). Collaborate with Clinical Development and Clinical Sciences for effective data surveillance Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree an accredited institution in a science or in a technical field such as computer science or mathematics required - Master's Degree preferred Experience Qualifications - 10 or More Years Bachelor's degree with minimum 10 years (or Master's degree with minimum of 7 years) proven experience required - 7 or More Years Previous experiences in R programming area, involved in R and/or Shiny app development and implementation. required - Advanced working knowledge of all aspects of the R and SAS programming language used in clinical trials programming. required - Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis required - Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials. required - Having knowledge of all phases of drug development, including early and late phase clinical development and submission required - Having solid background of applied statistics required - Solid knowledge of new advanced statistical methods using SAS or R required - Advanced knowledge in database structures and set-up required Travel: Ability to travel up to 10% Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $168,000.00 - $252,000.00 Download Our Benefits Summary PDF

Associate Director, Statistical Programming - R Implementation

oin a Legacy of Innovation - 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The purpose of this role is to support the processes that fall under the responsibility of the Procurement group. Coordinates with Procurement team members, Purchasing, Legal, Finance, vendors, and other functional groups as needed. This role performs activities such as contract execution, new vendor set-up and maintenance, simple negotiations, prepares for audits and inspections, maintains preferred supplier list, maintains and tracks Procurement training for compliance, troubleshoots payment delays, and other duties as needed. Responsibilities<ul><li>Contract Coordination: Collate exhibits to create contract draft, review contract documents for completeness and accuracy; ensure compliant routing of contracts for internal approvals and signatures, based on amount and signing authority; create Purchase request from executed contract; and update CLM system/trackers throughout the process.</li><li>Conduct Simple Negotiations: Review contractual amendment details against original contract. Ensure internal stakeholder and Finance alignment with scope of work and budget; apply judgment to challenge the need for change request; manage interactions with Vendor, finalize, and execute amendment.</li><li>Audit Ready/Inspection Prep: As per the audit requirement and processes, storage of critical procurement documents is required to be Audit/Inspection ready at all times; these documents must be clearly filed and retrievable. Perform quality audits on procurement documents filed by the Procurement team, periodically, to ensure audit readiness. Review and interpret stored documents to show appropriate information and follow up directly with individuals to close any gaps. To prepare for an Audit/Inspection, the first step is to create a Vendor List for the scope of the inspection. Work with a cross-functional team of Procurement, QA, and Stakeholder Leads to ensure all required vendors and documents are identified, reviewed, stored, and available when needed. Prepare redaction documents for an inspection or audit.</li><li>Maintain Preferred Supplier List: Update and ensure the list is accurate on a regular cadence. Track Procurement policy training adherence, ensuring all employees complete the required training on the timeline provided. Update training materials and employee listings as needed. Investigate vendor payment delays raised by Purchasing and Accounts Payable. Analyze system data, assess root cause factors, and determine actions needed to resolve the situation. Coordinate with Buyers, Business, Finance, Purchasing, Vendor, and Accounts Payable as needed.</li><li>Vendor Set-Up Maintenance: Onboard/update vendors in Zycus with vendor contact and company information. Maintain a status tracker and follow up with vendors for timely completion of profiles including W9/W8-BEN document. Confirm final profile and submit in Zycus for SAP creation.</li><li>As relevant, liaise with the Quality Assurance group to obtain QA risk rating and audit status for RDP vendors. Maintain this information centrally for all RDP vendors for up-to-date evaluations. Review and update questions and pending statuses with the Quality Assurance group on a regular basis.</li></ul>Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>High School Diploma required</li><li>Bachelor's Degree or an equivalent combination of education and experience preferred</li></ul>Experience Qualifications<ul><li>4 or More Years in outsourcing, health sciences, paralegal/contracts or related field preferred</li><li>Demonstrated ability to leverage digital data and analytics preferred</li><li>Demonstrated ability driving or participating in digital transformation initiatives preferred</li></ul>Equal Opportunity Statement Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate, Strategic Sourcing

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Business Architect Sales & Distribution Solutions is responsible for the analysis and design of business processes in this business area and is also responsible for the solution design and implementation. The role actively supports process management activities for the relevant stakeholders and coordinates process optimization initiatives and implementation of changes and projects. The support of daily operations (incidents, service requests, changes) for the functional modules in scope is also part of this role. Responsibilities<ul><li>Analyse, design and configure processes related to sales and distribution (supply chain management) and material management in the global ERP landscape, develop high level solutions for new demands from business and provide input for business cases</li><li>Collaborate with business stakeholders to gather and document requirements, translate business requirements into technical specifications for the SAP SD module.</li><li>Propose measures for business process optimization based on experience and feedback from issue and problem management. Implement best practices to enhance efficiency and effectiveness in sales operations.</li><li>Ensure the SAP SD/MM modules integrate seamlessly with other SAP modules and third-party systems, by working closely with internal and external support teams, as required</li><li>Responsible for the configuration and customizing of the SAP SD/MM modules to align with business needs, in partnership with internal and external support teams, as needed. Implement pricing, billing, shipping, and sales order management functionalities.</li><li>Lead or participate in SAP SD/MM implementation and upgrade projects, in close collaboration with other internal or external support teams.</li><li>Provide technical support to users and resolve issues related to the SAP SD/MM modules functionalities, as well as integration with other systems or applications, where applicable. Ensure the smooth operation and performance of the sales distribution business processes. Perform periodic monitoring of applications and interfaces in scope, including PI support with LSPs/3PLs.</li><li>Responsible for documenting all GxP changes in scope, in line with industry standards and regulations, by working closely with internal and external development and support teams, as required.</li><li>Tools and technologies like SAP sales distribution modules or material management, integration with other supply chain ERP technologies and processes (EDI support, IDOC monitoring, PI support, LSPs/3PLs etc.)</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Bachelor's Degree Bachelor's degree in IT or related field required Experience Qualifications 4 or More Years A minimum of 5 years of relevant professional experience required 4 or More Years Very good knowledge of business processes in Sales and Distribution area preferred 4 or More Years Very good knowledge of supporting SAP applications and workflows (SAP-SD and SAP-LES, ideally also SAP MM, EWM, GTS) preferred Strong customer and service focus Ability to analyse and resolve complex situations Strong communication, collaboration and good presentation skills Seniority in managing internal and external suppliers Good documentation skills, familiar with GxP requirements Result-oriented, flexible and reliable Travel Ability to travel up to 20% Ability to collaborate internationally, frequent travel to other regions is expected Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Business Architect, Sales & Distribution Solutions

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products. Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing, for less complex projects.<ul><li>At the time of implementation of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)</li><li>Serve as the Point of Contact (PoC) for gathering country/region specific CDx RA requirements from local RA team members (e.g. from Japan, China, Australia, Canada, Korea etc.)</li><li>For recruitment in EU: It is critical that this person has, and continues to develop regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR requirements to enable and support timely registration of both therapeutic and diagnostic products in the EU as well as UK and Switzerland.</li></ul> CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners specifically:<ul><li>Use of CTA/CDx within clinical trials</li><li>Device protocols and SAPs</li><li>Device non-significant/significant risk determinations (both submission to CDRH in a Q-sub process and in a streamlined fashion within protocol submission to CDER via the INDs), IDEs</li><li>Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.</li><li>Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)</li><li>ICF reviews to ensure adequate disclosure for collection, retention, testing and retesting of samples</li><li>Project Team Participation: Provide device-specific regulatory insight/guidance during CDx Indication Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with the creation of contingency/backup plans for CDx submission.</li></ul> Health Authority Submission Preparation : Assist with preparation of pre-submission documents and CDx related portions of therapeutic marketing applications and respond to regulatory queries/feedback from HAs. Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device submissions<ul><li>In collaboration with CDx lead work with Dx partners to ensure robust development of assay, participate in HA interaction for drug-related CDx topics/questions, and attend device company HA meetings as appropriate</li><li>In collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company positions related to CDx for Health Authority interactions (for both sponsor and partner side)</li></ul> CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these changes<ul><li>Assessing the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree required</li><li>Master's Degree preferred</li><li>Advanced degree in Pharm D, MD, PHD preferred Experience Qualifications</li></ul>Experience Qualifications:<ul><li>4 or More Years Solid scientific background Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of IDE submissions and approvals</li><li>Extensive experience developing companion diagnostics and devices.</li><li>Experience of drug development and drug regulatory procedures.</li><li>Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.</li><li>Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required</li></ul>Travel: Ability to travel up to 10% Occasional travel to Health Authority meetings in US and Europe, potentially Japan Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

CDx Associate Director, Global Regulatory Affairs

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Responsibilities - GLOBAL CHANNEL STRATEGY CREATION (LINKEDIN PRIORITY) - Lead the development and execution of a unified LinkedIn strategy that spans multiple regions, ensuring it aligns with corporate objectives and complies with local market regulations and standards. - Establish a consistent and standardized LinkedIn page experience across all regions, balancing global guidelines with the need for localized content and engagement. - Oversee social media agency supporting LinkedIn globalization efforts - Lead internal review process/submission for establishing global channel and develop global content criteria - Work directly with multiple LinkedIn reps to ensure contractual alignment and page infrastructure development/migration of channels and deactivate inactive channels across the various regions. - Create and enforce governance structures for LinkedIn usage, ensuring that all content, community interactions, and account activities comply with legal, regulatory, and corporate standards. - Collaborate with legal, compliance, and other internal stakeholders to ensure that LinkedIn practices are fully aligned with global policies and local regulations.-Monitor LinkedIn activity to ensure adherence to governance standards and best practices, proactively addressing potential risks or violations. - Obtain learnings to apply to future globalization standards of DS company-owned channels.-Partner with regional teams across marketing, communications, and HR to ensure a cohesive LinkedIn strategy that aligns with both global objectives and local market needs. - Serve as the go-to expert for LinkedIn governance, providing support and guidance to internal teams and regional stakeholders on best practices, compliance, and content management. - Develop and maintain an enterprise messaging strategy for replying to public messages and comments - Facilitate regular cross-functional meetings to ensure that global LinkedIn strategies are in sync with regional marketing and communications efforts. - Develop comprehensive playbooks and resources that define LinkedIn governance, content guidelines, community management strategies, and engagement protocols. - Lead the creation of change management materials to ensure the seamless adoption of global LinkedIn standards across the organization, including training, tools, and communication strategies. - Provide ongoing training, support, and resources to regional teams to help them understand and implement LinkedIn governance and best practices effectively. - ENTERPRISE GOVERNANCE SUPPORT - Support the head of Enterprise social media with the creation of company-wide standards, security measures and other policies/procedures to ensure complaint and best practice social media operations including but not limited to user access, password security, etc. - Oversee social media channel registry portal - Identify complaint model for global user access/publishing including but not limited to Business Manger based assess and/or identifying global complaint publishing platform - will include overall support of rolling out model and necessary training materials. - Establish global channel/content criteria model based off learnings/guidance established in defining LinkedIn structure - Build process efficiencies across social media submissions and adjust and manage the social approval process across an array of stakeholders - Help establish global content criteria standards and structure. - Execute social governance strategy across the enterprise including updating policies, monitoring trends and working cross-functionally to ensure the risk to Daiichi Sankyo is minimized. - DAIICHI SANKYO SOCIAL MEDIA FORUM - Help establish, plan and facilitate regular meetings with regional social media counterparts to provide updates on Enterprise progress, share best practices and facilitate internal knowledge sharing - Provide training(s) of new resources to regional social media users - Create feedback loop to assess regional needs that may require Enterprise support/investment for future tools/technologies/resources/etc. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree required Experience Qualifications - 7 or More Years Experience in social media management, including global social media strategy - focusing on governance and compliance. Proven track record of managing social media channel standards and governance, particularly on LinkedIn, within a global or enterprise-level environment. required - 5+ year experience developing and implementing social media policies and governance frameworks, playbooks ensuring adherence to legal, brand, and compliance standards across regions AND experience working cross-regionally to effectively train regional stakeholders. required - 5+ years experience with social media enterprise software, particularly publishing, listening and metrics tools such as Hootsuite, Khoros, Sprinklr, Klear, Meltwater, Talkwalker or other comparable tools required - 3+ years experience in a highly regulated industry such as finance, technology, healthcare/pharmaceuticals, as well as social media crisis management are preferred preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $146,480.00 - $219,720.00 Download Our Benefits Summary PDF

Channel Lead, Enterprise Social Media

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Deliver the development and implementation of systems and programs to support the business functions of Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. Develop a strong, positive strategic business partnership with various business functions of Daiichi Sankyo. As a trusted partner, provide oversight of business demand to balance IT portfolio and to ensure that partners receive the highest possible business value, while subscribing to the enterprise IT strategy. Responsibilities Strategic Leadership, Platform management and Governance:<ul><li>Implement and lead the global strategy for process automation, RPA, and low-code/no-code platforms, ensuring alignment with business objectives</li><li>Oversee and evolve Center of Excellence (CoE) for automation, setting governance policies, best practices, and security standards</li><li>Drive adoption of low code automation platforms (UI Path, Power Platform and others), ensuring scalability, governance, and integration with enterprise systems</li><li>Promote a culture of Kaizen (continuous improvement) and innovation, aligning with Japanese & other global work principles</li><li>Implement and continuously improve framework for citizen development, empowering business users to create automation solutions within a controlled governance model</li></ul>Intelligent Process Automation & RPA Implementation:<ul><li>Lead the deployment and optimization of RPA solutions using UI Path and other automation technologies across business functions</li><li>Implement automation of workflows to drive intelligent decision-making, and self-learning systems</li><li>Oversee process mining and discovery initiatives to identify high-impact automation opportunities</li><li>Ensure seamless integration of automation solutions with ERP, HR, finance, supply chain, and collaboration platforms</li><li>Collaborate closely with regional & global teams to gather insights, ensuring automation solutions are tailored to local needs while maintaining global standards</li></ul>Citizen Development & Low-Code Application Platforms:<ul><li>Provide an oversight for global citizen development initiative as per existing strategy document providing governance, training, and toolkits for business users to build automation solutions</li><li>Oversee the adoption and governance of low-code/no-code application platforms like Microsoft Power Platform, UI Path Apps, Appian and others</li><li>Foster a self-service automation culture, enabling employees to create workflow automation</li><li>Collaborate with security, infra & data teams to ensure controlled, scalable, and compliant citizen development practices</li></ul>Budget Management, Change Management & Adoption:<ul><li>Oversee budget planning and allocation for automation initiatives, ensuring cost-effective investments with measurable ROI</li><li>Drive organizational change management (OCM) to ensure successful adoption of automation, RPA, and low-code platforms</li><li>Develop training programs, knowledge-sharing sessions, and certification pathways to upskill employees in automation technologies</li></ul>Performance Monitoring, Continuous Improvement & Knowledgebase<ul><li>Define KPIs and success metrics to measure the impact of automation, including efficiency gains, cost savings, and user adoption rates</li><li>Define and execute a strategic roadmap for adopting new technologies, ensuring alignment with business goals and evolving industry trends</li><li>Implement strategies to retain critical knowledge in-house, reducing dependency on external vendors and ensuring long-term sustainability of automation initiatives</li></ul>People Management Leadership role overseeing employees from Japan, the U.S., and other countries, setting goals, defining objectives, and conducting year-end assessments. Responsible for managing and mentoring a team of junior staff, on-site and offshore consultants, providing guidance, technical feedback, and fostering a collaborative, multicultural work environment. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's degree in computer science, Information Systems or related field required Experience Qualifications<ul><li>At least 10+ years of experience in process automation, RPA, AI-driven automation, and low-code platforms, leading global digital transformation initiatives</li><li>Expertise in UI Path, Microsoft Power Platform, and other automation tools, driving large-scale workflow optimization, AI integration, and process mining</li><li>Proven global people management experience, especially in Japan and other countries, is a must.</li><li>Experience in budget management, vendor negotiations, and ROI-driven technology investments, ensuring cost-effective and sustainable automation programs</li><li>Strong leadership in cross-functional collaboration, working with regional teams, IT, business stakeholders, and external vendors</li><li>Experience in working within the framework of SDLC, SIAM</li><li>Relevant certifications in automation and low-code platforms are a plus, such as UiPath Certified Professional, Microsoft Power Platform Solution Architect and Appian Certified Developer</li></ul>Travel Ability to travel up to 10% Travel to DSPD, DSD, DSE, DST locations which will include overnight travel. Ability to travel to US, EU and Japan. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Digital Transformation Lead, Automation

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This position will lead the valuation processes for in-licensing, out-licensing, co-development and/or acquiring opportunities. Accountable to own the financial evaluation model developed in close collaboration with Global Business Development (US, Japan, EU teams), Finance (Corporate FP&A & R&D), Global Commercial & Strategy, Global Forecasting & Insights and Global Project Management. Successful execution will involve working cross-functionally to gather relevant information, synthesize the materials, and develop comprehensive opportunity assessments consistent with our corporate business development strategy. This position may lead a small team and will report to the Head of Forecasting/Business Analytics and Deal Valuations. Responsibilities: Cross-functional Collaboration: <ul><li>Collaborate with and lead cross functional teams (global/regional RD, IP, Legal, Finance, Forecasting, Manufacturing/Supply Chain, Commercial) to evaluate and execute on deal opportunities, including managing the interface with global/regional teams and ensuring alignment with project assumptions.</li><li>Collaborate and set stage with the wider GBD team to formulate partnering strategy and objectives by providing insights and making recommendations with significant potential impact.</li></ul> Deal Valuation NPV Modeling Financial Support: <ul><li>Provide independent and high-quality financial support to all BDL transactions including In-Licensing, Out-licensing, Collaborations, and other strategic business initiatives.</li><li>Develop valuation model, including sourcing and validation of key assumptions and data from global cross-functional teams (Marketing, RD, Finance, Supply Chain, etc).</li></ul> Deal Valuation Analysis: <ul><li>Lead analysis of financial analysis and models underpinning deal terms; analyze deal economics quickly to identify key value drivers and looks at key sensitivities. Preparation of financial aspects of business cases including valuation, PLs, cash flow analyses, sensitivity analyses, and other relevant financial metrics slides for presentation to governance committees.</li><li>Orchestrate and drive detailed comparator deal analysis and run valuation scenarios to align proposed terms for new collaborations.</li></ul> Post Deal Support Analysis: <ul><li>Post deal support to DS Tokyo External Auditors, including asset Impairment Test analysis (explain deal structure, rationale and source of assumptions and key data supporting the deal valuation model)</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) <ul><li>Bachelor's Degree Concentration in Finance/Business/Accounting is preferred required</li><li>MBA Top tiered business school is highly preferred</li></ul>Experience Qualifications:<ul><li>10 or More Years Pharmaceutical/Biotech/Life Sciences/Investment Banking industries experience required</li><li>2 to 4 or More Years BD&L transactions financial modeling preferred</li><li>Ability to travel up to 20% Business meetings and/or conferences as required.</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Director, Finance - Business Development Financial Evaluations

Join a Legacy of Innovation 110 Years and Counting! Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. SummaryThrough strategic leadership, lead and manage skills and capabilities development initiatives for the Global Finance and Procurement organization and oversee project management for Finance, driving coordination, communication, and change management across various initiatives. Through a passion for capability building and strong project management skills, this role will engage with diverse stakeholders across global teams. Work closely with project teams to ensure that changes are smoothly and successfully implemented to achieve lasting benefits. Own the road map, oversight and change management of the entire portfolio of special projects. Play a key leadership role in support of all processes and procedures around change management. This role requires comfort and independence in leading complex initiatives of high dollar value from inception through to implementation and ability to handle global projects through established interactions with Japan and Europe as required. Responsibilities - Lead the Global Finance and Procurement Capability Building Program - Design a comprehensive training program for Global Functional Skills Finance, Procurement, and other functions of the Global Corporate Planning Management team. The objective is to design and manage sustainable global train-the-trainer program - Perform periodic skills gap analysis to identify areas of focus across regions and functions and set training objectives - Oversee ongoing and relevant content development and execution of the training programs. This includes coordinating across teams, identifying trainers and coaches, ensuring participants have the resources they need - Continuously assess the effectiveness of the training program through feedback and performance metrics - Collaborate with HR Learning Development to ensure the training program is current, capabilities matrix aligns with the industry trends and organizational needs, and performance management process incorporates learning and development metrics - Project Leadership and Collaboration - Support DSI Finance by managing and tracking various departmental initiatives, ensuring alignment with organizational goals. - Responsible for the development and management of ad hoc special projects as they arise - Develop and maintain processes for measuring progress, reporting outcomes, and effectively communicating updates to stakeholders. Develop the report and communication channel. - Act as the lead to coordinate and be accountable for the delivery of said projects, this includes working closely with the other team members also assigned to these projects. - Create the resourcing plan for each project and report it to the Global RD Procurement LT in a concise and clear way so that resourcing issues/constraints can be clearly managed by LT. - Lead change management efforts related to Finance initiatives, ensuring successful adoption and sustainability of new processes - Display cross-divisional leadership by enhancing reporting clarity and communication of key information among groups; Maintain strong relationship within US Finance and Procurement teams, as well as Global GCPM teams, CFO Leadership team - Lead change management efforts related to Finance initiatives, ensuring successful adoption and sustainability of new processes - Develop and implement change management strategies and plans that maximize employee adoption and minimize resistance - Conduct impact analyses, assess change readiness, and identify key stakeholders - Align on change management approach and steps with HR, Finance Procurement leadership team in the US and Globally - Engage finance procurement leadership teams in change management efforts - Establish metrics to measure the effectiveness of change initiatives. - Monitor progress and report on the status of change management efforts. - Identify and address any issues or obstacles that may arise during the change process Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree Business, Communications, Project Management or HR/Learning & Development (preferred areas of study) required - Master's Degree preferred Experience Qualifications - 10 or More Years Functional experience in Project Management, Business Operations, Finance, or related area required - Demonstrated success in program/project management, stakeholder engagement required - Demonstrated people leadership skills required - Experience working within global, cross-cultural environment. Japan business a plus; Bilingual a plus preferred TravelAbility to travel up to 20% Business meetings and/or conferences as necessary; Audit training programs in other regions Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Director, Finance Project Management & Capabilities Building

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Director US Medical Affairs (USMA) Oncology, under the direction of the Senior Director, USMA Oncology (US Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. The role is primarily responsible for US Medical Affairs Strategy and overseeing execution of medical activities for assigned indication(s) and asset(s) and will have the responsibility of managing multiple direct reports. Responsibilities - Leads the development of the US Medical Affairs strategy and execution of the US Medical Affairs plan for select indications/projects related to evidence generation, medical information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing budgets and resources for the assigned medical affairs plan activities, in collaboration with Sr. Director. - Leads medical readiness activities for market launches. This includes strategic partnerships with the brand team, HEOR (Health Economics and Outcomes Research), RD (Research Development), FMA (Field Medical Affairs), MIE (Medical Information and Education) and global functions as necessary to create and implement strategies that support launch. Provide medical support/input into commercial and market access discussions for select indications. - Provides medical leadership in interactions with key external stakeholders including scientific leaders, payers and societies; lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound. - Responsible for scientific communications and publications; interpretation of clinical data; ensuring consistency of clinical content and scientific statements across materials; training or communication of emerging data (internal or competitive), such as congress updates and development program highlights; and budget and forecast accuracy - In a matrix environment, represents US interests and business needs in shaping development and life cycle management strategy for select indications/projects. Reviews Externally Sponsored Research (ESRs) and may serve as deputy regional medical lead in Global IIS Review Committee meetings. May serve as medical lead for select company-sponsored evidence generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with USMA Clinical Operations and other cross-functional and regional stakeholders. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - An advanced doctorate degree (PharmD, Ph.D., MD, DO, or equivalent) in a medical/ scientific area is required. Experience in oncology therapeutic area is required Experience Qualifications - 10 or More Years overall related experience or commensurate education/experience required - 4 or More Years experience in pharma at local, regional and/or Global level. preferred - Excellent knowledge of current clinical practice in Oncology / Hematology or other relevant disease area. preferred - knowledge in and understanding of medical activities (including scientific communications, medical information, MSLs, and HEOR), relating to the commercialization of oncology products preferred Travel Ability to travel up to 20% Standard office based physical demands, travel as required. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $198,160.00 - $297,240.00 Download Our Benefits Summary PDF

Director, Medical Affairs Oncology

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary<ul><li>The position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at least one therapeutic area or a large, global Phase 3/4 program.</li><li>This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this position regularly interfaces with key high-level internal and external stakeholders and approves regulatory reports/submissions using expert safety knowledge.</li><li>This position independently addresses the most complex safety issues and acts as the final decision-maker for certain safety-related issues, approving various safety documents. In addition, this position interacts with internal stakeholders and provides mentorship in talent development among CSPV organizations working with Head of CSPV.</li><li>Overall, this position has both leadership and management responsibilities and is considered a global leader for a therapeutic area or a large program in CSPV organization.</li></ul>Responsibilite<ul><li>Leading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and risk management activities for his/her portfolio. Serves as the company's senior representative with key high-level internal and external stakeholders on important drug safety issues supporting Global Medical Safety Lead. Responsible for safety governance/oversight of Clinical Safety and risk management activities. Providing adequate and proper management of resources to support all projects and maintain business continuity.</li><li>Managing productive cross-functional Medical Safety collaborations within and across line functions, e.g. Clinical Development, Medical Affairs, Regulatory Affairs, Clinical Operations. Formulates strategic approaches for risk mitigation for global products/TAs and ensures these activities are properly carried out. Serves as company expert for risk mitigation and oversees the global communication of important product safety information.</li><li>Create and align processes that address global CSPV objectives by working with CSPV senior management and leadership. Provide coaching, motivate, direct, and foster teamwork, lead cross-functional, multi-cultural teams to develop talents among CSPV organization. Lead special projects cross-functionally as needed</li><li>Enhancing the scientific and clinical experience for all CSPV staff through continuous training and coaching. Building the talent pipeline, attracting, retaining, and developing talents within CSPV.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>MD is required.</li></ul>Basic Qualifications<ul><li>At least 15 years of professional drug development experience in a major pharmaceutical company, including at least 7 years in global medical safety.</li><li>Oncology expertise is strongly preferred.</li><li>Experience responsible in leading roles in clinical or safety through complete submission process & in submission of data to health authorities.</li><li>Proven strong leadership in coaching, mentoring, fostering teamwork with experience in leading multi-cultural, cross functional teams.</li><li>Ability to maintain and develop effective work relationships with subordinates, superiors and peers.</li><li>Strong negotiation and conflict management skills.</li></ul>Travel<ul><li>Must have the ability to travel domestic and global up to 10%</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $316,725.00 - $527,875.00 Download Our Benefits Summary PDF

Executive Director/Head of Medical Safety Oncology Assets

Join a Legacy of Innovation - 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. The is a Director-level position. JOB SUMMARY &bull;Be accountable for all Statistics activities conducted for a specific therapeutic area and/or customer (Health Economics and Outcome Research (HEOR) / Health Technology Assessment (HTA) or Medical Affairs), at Global, Regional and local levels, by Data and Statistical Sciences for Evidence Generation (DSS-EG), in collaboration with the Global Head of DSS-EG and global partners and stakeholders. The accountability will include the definition and execution of the vision, direction and strategy of the Statistics team within the area of responsibility as well as the development and execution in time, in quality and in budget of each statistical activities conducted, based on both primary and secondary (RWD) data, under the business lead of Global, Regional and local Business Partner. &bull;Ensure the execution of departmental activities in compliance with legal and pricing and/or regulatory authority requirements in each global region, as well as manage Statistics activities under responsibilities in front of internal and external audits and inspections. &bull;Be responsible for the performance of the global department and for the management and development of the team members as well as mentors or acts as functional manager of staff residing in other offices as needed. &bull;Collaborates with our business partners to recommend and implement a Data Strategy within the area of responsibility by capitalizing both primary and secondary data sources. Ensure solid networking and partnership with relevant internal and external stakeholders to leverage capabilities within the area of responsibility, drive operational excellence and foster innovation. &bull;The position will have extensive experience in the area of Statistics under responsibility, including leadership and line management, excellent interpersonal skills, experience in Medical Affairs or HTA /Pricing and Reimbursement activities, advanced knowledge of relevant statistical methodology (including in RWE, Patient Reported Outcomes and/or Observational research) and of industry standards as well as proficiency in project management and vendor partnership skills. RESPONSIBILITIES Business Leadership and Strategy<ul><li>Leads the strategy of the Statistics within the area of responsibility, in alignment with Global Head of DSS-EG as well as with global partners and stakeholders. Within the scope of responsibility, reviews and provides strategic input to portfolio under responsibility throughout product life cycle, and briefs senior management as needed. Ensures appropriate and proactive networking with key stakeholders, understands incoming business needs, may represent the function in cross-functional teams, and implement Global DSS vision and strategy in the organization.</li><li>Defines and implements sourcing strategy for the activities under responsibilities, including the level of outsourcing and/or insourcing, in alignment with Global Head of DSS-EG.</li><li>Accountable for implementing appropriate statistical methodologies and ensuring the optimal usage of advanced analytical approaches in the area of responsibility. Monitors and enforces compliance with policies, standards, standard procedures and processes as well as is responsible for regulatory audits and inspections in the area of responsibility.</li></ul>Portfolio lead for Data and Statistical Sciences for HEOR/HTA Evidence Generation. <ul><li>Is responsible for development, conduct and execution of all Statistical activities in the perimeter, based on both primary and secondary (RWD) data, in time, in quality, in budget as well as in alignment with Global, Regional and Local Business Partner strategies through collaboration with internal and external stakeholders. Statistics activities include inputs for the development of primary data collection study protocols and secondary database study protocols (statistical design and analysis strategy), Statistical Analysis Plans (including for secondary usage of data), analyses execution supervision and guidance for proper interpretation of statistical results.</li></ul>Team Leadership & Management <ul><li>Proactively identifies and manages risks at the functional level and/or for assigned programs, and/or initiatives. Functions as Statistics escalation point for all studies and projects under responsibility. Is accountable for the effectiveness, quality and compliance of all study and project documents in the area of responsibility.</li><li>for recruiting, retaining, coaching, developing (both in technical and soft skills), and managing individual contributors and potential line Managers within his/her department. Is responsible for the performance of the global department. Identify staff training needs and ensure implementation of team development and departmental compliance training. Ensure efficient resources and talents management across regions. Mentor or act as functional manager of staff residing in other offices as needed.</li></ul>Sourcing and Vendor oversight<ul><li>Final accountability for all the Vendors providing statistics services for projects under responsibility. Responsible for managing high-level governance, negotiations and partnerships with vendors. Is accountable for budget, resources and timelines with external vendors including contract research organizations (CROs) for multiple projects across the department and ensures timely delivery of high-quality deliverables at reasonable cost.</li></ul>Operational Excellence and Innovation<ul><li>Leads the development and implementation of global vision and strategy to leverage innovation and operational excellence in Statistics for his/her team, grounded in current and emerging best practices and trends. Identifies opportunities and leverages network with internal / external stakeholders to lead, contribute to, and/or develop Statistics processes, standards and standard procedures to ensure compliance with legal and international guidelines and good practices across the global regions, while fostering the development of future success of the organization. Drives Statistics Innovation activities, in collaboration with DSS-EG Statistical Innovation, as well as makes recommendations for global/regional implementation. Leads and/or participates in Global functional and/or multi-functional / multidisciplinary teams and initiatives to enhance harmonization and efficiency across studies and projects under responsibility. Leverages Statistical expertise related to the assigned scope to promote best practices across the Drug Development lifecycle. Any other duties deemed pertinent to the needs of the business.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Master's Degree MSc in Biostatistics in Statistics, Mathematics or related field is required.</li><li>A PhD preferred.</li></ul>Basic Qualifications<ul><li>Must have 10+ years of professional experience in statistics within pharmaceutical industry, medical device, or similar environment (e.g. CRO) of which at least 5 years in Pharma and 3 years in evidence generation space.</li><li>A Minimum 5 years of line management and leadership experience</li><li>Experience in Oncology in conducting clinical programs and studies, including experience in late phase projects.</li><li>Extended and up-to-date knowledge of statistical methods and statistics applications in the industry across product life cycle, in particular in Observational Research, RWE and Patient Reported Outcomes.</li><li>Demonstrated expertise and experience in HTA and Pricing and Reimbursement activities, including the use of RWD, with significant experience with payer, as well as experience in the creation, management, and execution of processes and guidance documents.</li><li>Extensive and significant knowledge of key pharmaceutical industry best practices as well as legislative, regulatory and industry artifacts/frameworks.</li><li>Must have excellent communication skills in particular the area of active listening, coaching and influencing, both oral and written.</li><li>Demonstrated strong leadership, strategic thinking and excellent collaboration skills along with a proficient entrepreneurial mindset.</li><li>Advanced project management skills with the ability to manage multiple projects and prioritize tasks effectively, alongside demonstrated experience in continuous improvement and change management.</li><li>Must have experience in CRO management at governance level.</li></ul>Travel Ability <ul><li>Must have the ability to travel both domestic and international up to 10% to 15%</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $189,520.00 - $284,280.00 Download Our Benefits Summary PDF

Global Head, Statistics Oncology HEOR/HTA

Join a Legacy of Innovation - 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities per audit program of GxP relevant audit activities for the Daiichi Sankyo's GxP group and its partners as applicable ensuring the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections across the organization and affiliates as appropriate for the area of GxP audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports and Common Technical Document submission. Responsibilities<ul><li>Support audit program for clinical studies and vendors as applicable for the area of GxP audits assigned in alignment with the Master Audit Schedule, using a risk-based approach to ensure the Audit Plans are aligned with the company's strategy and objectives and adjust the plan as needed to support business functions, internal and external stakeholders to execute audits effectively.</li><li>Support inspection readiness by preparing clinical teams, Clinical Safety and Pharmacovigilance (CSPV) and post marketing stakeholders for key Health Authority pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that evidence is archived.</li><li>Ensure up to date audit CAPA information in the eQMS in a timely manner.</li><li>Support CAPA completion for all outsourced audits with Development and Medical QA, PV QA, QMS and stakeholders.</li><li>Collaborate with QMS Team and applicable QA function to ensure no overdue CAPAs.</li><li>Conduct document audits including, but not limited to Common Technical Document (CTD), Clinical Study Report (CSR) and Nonclinical Study Report (NCR), electronic Trial Master File (eTMF) and other pivotal documents to be submitted to the regulatory authorities for application</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree in a scientific, healthcare or related discipline required</li></ul>Experience Qualifications<ul><li>Must have at least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document review</li><li>Must have at least 4 or more years proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials and creation of regulatory submission documentation with the ability to provide interpretation and guidance for internal and external customers on GxP related regulations / guidelines (e.g., FDA, EU, ICH) and company procedures and policies.</li><li>International experience including EU and Japan preferred</li><li>Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products preferred</li><li>Proven experience with Health Authority Inspections, (e.g., FDA, HPFB, MHRA and other European regulatory agencies) preferred</li><li>Expertise working within early development through Phase III and Pharmacovigilance studies preferred</li><li>Medical, technical writing experience a plus</li></ul>Travel Ability Must have the ability to travel up to 25-30% domestic and international. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $116,400.00 - $174,600.00 Download Our Benefits Summary PDF

Manager GCP/Document Audits

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi Sankyo's GxP group. Together with regional management teams plans, will support, conducts and reports internal systems and process audits across the organization as appropriate for the area of GxP audits assigned. Responsibilities:<ul><li> Execute the audit program for internal systems as applicable for the area of GxP audits assigned in alignment with the Master Audit Schedule using a risk-based approach to ensure the Audit Plans are aligned with the company's strategy and objectives and adjust the plan as needed to support business functions and internal stakeholders to execute audits effectively. </li><li> Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews systems and procedures. </li><li> Ensure trending and signal detection is communicated to stakeholders for risk mitigation. </li><li> Support the stakeholders in identifying and defining quality improvement initiatives for development activities / programs post internal system audit. </li><li> Support reporting of quality metrics for audits and inspections and execute against these metrics consistently. </li><li> Provide inspection management support regarding compliance concerns identified during internal systems audits, remediations implemented and CAPAs pending. </li><li> Support Risk Mitigation programs to ensure compliance to regulatory guidelines </li><li> Ensure up to date audit CAPA information in the eQMS in a timely manner. </li><li> Collaborate with QMS Team and applicable QA function to ensure no overdue CAPAs. </li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>Must have a BS degree in a scientific discipline.</li></ul>Experience Requirements:<ul><li> Must have at least 6+ years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance </li><li>Must have proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials. Ability to provide interpretation and guidance for internal and external customers on GxP related regulations / guidelines (e.g., FDA, EU, ICH) and company procedures and policies.</li></ul>Competencies:<ul><li> Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products </li><li> Proven experience with Health Authority Inspections, (e.g., FDA, HPFB, MHRA and other European regulatory agencies </li><li> International experience is a plus; but at minimum experience working with diverse cultures and employees </li><li> Expertise working within early development through Phase III and Pharmacovigilance studies preferred </li></ul>Travel:<ul><li>Must have the ability to travel up to 15% domestic and international</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $116,400.00 - $174,600.00 Download Our Benefits Summary PDF

Manager, Internal Process Audit

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Manage Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Contribute as a key DSI contact for PV service providers to address, escalate issues requiring attention or resolution, and proactively drive operational excellence and continuous improvement. Manage DSI's Strategic PV Partnerships and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI contracts that are PV relevant and AE reporting language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received from CSPV vendors. Responsibilities: Strategic Partner Management: <ul><li>Manage Local/Global PV service providers responsible for Call Center, individual safety case processing, and aggregate reporting.</li><li>Establish and maintain collaborative relationships with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.</li><li>Facilitate operational meetings with CROs, License Partners, and PV vendors.</li><li>Assist with PV oversight of the DSI Call Center.</li><li>Manage oversight of ICSR processing activities including, Safety Information submission to Health Authorities and License Partners, Reconciliation with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and other suppliers.</li><li>Ensure adequate training of resources to enable quality of deliverables. Manage quality, efficiency, and resources for PV service providers/vendors.</li><li>Measure and monitor performance of vendors against service level and KPIs.</li><li>Manage the development of governance, business continuity, quality, and vendor monitoring plans. Maintain oversight for capability development of service provider and resources.</li><li>Plan, allocate, and utilize resources and prioritize assignments. Contribute to management and escalation of issues for resolution.</li><li>Coordinate vendor assessments and make recommendations on vendor partners. Manage the coordination of PV participation in due diligence for acquisitions and divestments.</li><li>Assist with negotiation and transfer of PV Business in case of Product Divestment. Collaborate with DSI audit groups to ensure comprehensive auditing of Business Partners as required to assure compliance with PV agreements.</li><li>Participate in audit and inspection readiness activities. Provide input for re mediating PV system deficiencies cited in audit/inspections. Manage the implementation of effective corrective and preventative action</li></ul>PV Agreements and Contracts: <ul><li>Manages PVAs/SDEAs and maintains oversight of PV relevant contracts. Contribute to overseeing and setting standards for PV contract management. Review contributes to revision of DSI contracts under negotiation (e.g. development, license, distribution agreements)Manage, negotiate, revise document collaborative license partner safety agreements with counterparts from (license) partner companies. Participate in the development and maintenance of a PVA repository. Contribute to the development of standard processes and contract templates in cooperation with Legal Department and PV functions. Assist in the development of standards for information exchange with partners in cooperation with PV functions. Initiate the implementation of obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence</li></ul>PV Regulatory Intelligence:<ul><li>Contribute to the management of PV Regulatory Intelligence and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PV regulatory intelligence reports received from CSPV vendors.</li><li>Management Strategy and Goals: Assist CSPV Leadership in developing PV goals, continued compliance, and strategy for process improvement initiatives.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>Bachelor's Degree Nursing, Pharmacy, Life Sciences, Health Care or related field required</li><li>Master's Degree Life Sciences preferred</li><li>PharmD Life Sciences preferred</li></ul>Experience:<ul><li>Minimum of 3 years of management experience in PV preferred</li><li>Minimum of 5 years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products; required</li><li>4 or More Years Knowledge of Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP) required</li><li>4 or More Years Knowledge of FDA regulations, clinical and safety databases; preferred</li><li>4 or More Years Familiarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP), PharmD, RN, or master's degree in life sciences preferred</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $124,960.00 - $187,440.00 Download Our Benefits Summary PDF

Manager, PV Strategic Partner Management

Join a Legacy of Innovation - 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This role is responsible for partnering with DS internal senior stakeholders to lead, assess, develop, negotiate, and execute strategic sourcing activities (both U.S. and Global) from RFP through to contract execution. Leads all aspects of strategic sourcing to ensure best value (cost, quality, Account Mgmt, timelines) for the businesses. Performs in-depth bid analysis and complex negotiations for efficiencies. Harnesses enterprise-wide knowledge and perspective coupled with in-depth functional knowledge to process, analyze, and prioritize value options that optimally benefit the stakeholders, DSI, and DS Group. Develops comprehensive global category management strategies to uncover strategic insights to help influence and inform Business decisions. Proactively seeks out and recommends new process improvements to optimize and enhance efficiencies and ways of working. Takes ownership and project manages a high volume of high-level projects which involves working with suppliers and internal stakeholders to define scope and review of work orders and agreements. Mitigates supplier issues and develops action plans to resolution. Leads supplier relationship management to ensure suppliers are meeting expected performance levels and driving innovative ideas for potential Brand application. Responsibilities<ul><li>Leads all strategic sourcing efforts from vendor assessment, RFP, negotiation, award, and contracting with senior business stakeholders for DS products and alliances.</li><li>Develops comprehensive global category management strategies which involves in-depth spend analysis, identifying opportunities, key insights, marketplace intelligence, and trends, to help inform Business budgeting and supplier utilization decisions.</li><li>Partners with senior business stakeholders across functions to understand business objectives and create annual plans to align objectives with sourcing strategies and solutions to achieve optimal results. Ensure that procurement policies and methodologies are understood and utilized. Serve as the lead relationship manager" to deliver best practices to the business partners.</li><li>Leads supplier relationship management to ensure supplier performance meets expected services levels and drives and enables innovation for potential Brand application, and continuous improvement.</li><li>Leads complex bid analysis, commercial contract negotiations, and execution, partnering closely with internal stakeholders such as Marketing, Legal and IT etc.</li><li>Ensures contracts include the appropriate terms and conditions for cost, quality, payment terms, timelines, and mitigates any risk; while ensuring all contracts are executed in accordance with company policies.</li><li>Develops and executes risk management strategies designed to protect DSI and DS Group and assure continued supply of goods and services.</li><li>Accountable for delivering cost reduction and value-added benefits to meet annual department and Business savings targets. Measure savings/value delivered to the business by utilizing an approved global savings calculation methodology savings tracking tool which includes both cost reduction and cost avoidance.</li><li>Proactively seeks out and identifies new areas of opportunity to drive additional sourcing value as well as identify, evaluate, and recommend best-in-class processes and tools.</li><li>Works closely with Procurement Operations to integrate the Small Business Administration plan and P2P continuous improvement into all sourcing activities.</li><li>Demonstrates thorough understanding of procurement processes/procedures, business, and legal language in contracts and supplier management.</li><li>Develops strong relationships with preferred suppliers. Actively manage preferred supply base for assigned categories and reinforce compliance.</li></ul>Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree required</li><li>MBA and/or Certified Professional in Supply Management (C.P.S.M) highly desired</li></ul>Experience Qualifications<ul><li>5 years strategic sourcing experience required</li><li>Experience in strategic sourcing, supplier management, and contract management required</li><li>Indirect procurement and pharma experience is preferred</li><li>Experience working with an e-Procurement tool is preferred</li><li> Experience leading and participating on cross-functional and/or global teams required</li><li> Internal stakeholder management, category management, process and continuous improvement expertise, project management and supplier performance measurement skills is required</li><li> Procurement process knowledge, contract management, financial analysis, market analysis, supplier analysis, supplier management, supplier diversity is required</li><li> Marketing Procurement experience in the pharmaceutical industry including but not limited to Creative Agencies, Media Planning and Buying, Market Access, Market Research, and Patient Assistance Programs. Is Preferred</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Strategic Sourcing

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI. This is a US Medical Affairs, Field based role. This territory currently covers the following states: KS, MO, AR, LA, MS, AL, Panhandle FL Responsibilities: Builds and maintains professional relationships with healthcare professionals (HCPs) by developing the skills and with guidance, implementing the following: <ul><li> Presenting disease state and Daiichi Sankyo product specific data to HCPs </li><li> Responding to unsolicited requests for medical information </li><li> Identifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boards </li><li> Gathering customer insights regarding DSI and competitor products to help inform medical and commercial decision-making </li><li> Enhanced professional expertise through attendance of select scientific meetings and professional conferences for the purpose of continuing education and scientific exchange with key opinion leaders </li><li> Develops positive working relationships with local and regional internal stakeholders to enhance DSI HCP relationships </li><li> Develops the ability to apply the appropriate methods to implement the FMA department strategy within his/her geography in alignment with Medical and Brand strategies </li><li> Completes administrative duties, including monthly expense reporting and field activity reporting </li><li> Represents the Medical Science Liaison function by participating in DSI meetings, functions, events </li></ul> Additional duties and responsibilities are based on position level/title, and may include but are not limited to: <ul><li> Provides innovation in enhancing and developing professional relationships with national and regional healthcare opinion leaders and HCPs to provide medical and scientific support for DSI initiatives. </li><li> Ability to anticipate trends and capitalize on opportunities </li><li> Lead special projects/initiatives. </li><li> Assist in the development of team members </li><li> Represent FMA leadership at DSI meetings, functions and events </li></ul> Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education: <ul><li>PharmD, MD, PhD or NP in a health sciences-related field or an equivalent combination of education and experience preferred</li></ul> Experience : <ul><li> MSL/Sr. MSL </li><li> 1 or More Years' experience, including medical & scientific affairs, clinical practice, research, academic or US-managed markets preferred </li><li> Previous experience in Oncology, clinical research and medical education preferred </li><li> Principal MSL/Associate Director MSL </li><li> 5 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred </li><li> Previous experience in Oncology, clinical research and medical education preferred </li><li> Must have a valid driver's license with a driving record that meets company requirements </li></ul> Compensation and seniority level/title based on experience and qualifications. Travel: <ul><li> Travel up to 60%. </li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $150,800.00 - $226,200.00 Download Our Benefits Summary PDF

Medical Science Liaison, Oncology Lung - Mississippi Delta

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Responsibilities:<ul><li>Supports positions from Director through Vice President, as needed, and in so doing will provide direct assistance to the project teams, committees and the department/function.</li><li>Attend GPT meetings and assist in creation of drafts of presentations, meeting agendas and action items.</li><li>Utilizes independent judgment and makes decisions in responding to questions related to assigned matters, processes, and procedures as applicable. Has in-depth knowledge of company policies related to assigned areas.</li><li>Identify and implement projects or process improvements with general supervision, for example, more efficient ways of working within GPM&L or on a project team, enhanced collaboration tools, etc.</li><li>Schedule and implement on-site/off-site & virtual meetings, (e.g., Project Team, Alliance, Ad hoc, Steering committee, Ad board, workshops, Investigator & Governance meetings). This includes, but is not limited to, the following: scheduling of meetings and logistics, creating meeting agendas, work directly with cross-function teams & Corporate IT to ensure telepresence and logistics are arranged prior to the meeting and maintained to ensure smooth conduct of the meetings. Responsible for accurate and timely processing of all business requests for project team.</li><li>Support Directors through Vice President, as requested, with a strong commitment to confidentiality and handling of sensitive documents and project information.</li><li>Assist with GPM&L department-initiated meetings and/or trainings (as assigned). GDP training, GPM&L Project Review Meeting, GPM&L Staff Meeting, GPM&L Records Management Training, etc. Prepare agenda and assist in management of monthly meetings. Maintain Outlook GPM&L member lists. Coordinate and attend GPM&L team building activities.</li><li>Directly support GPT & GPM across all indications for designated assets. Assist in updating Project & Portfolio Management Integrator (PPMI) and project timelines. Manage, administer & maintain SharePoint site including access to GPT and CSST meeting materials and master documents. Working with outside vendors such as key opinion leaders, assist with developing contracts and scheduling meetings with KOLs in conjunction with meeting & events group. Manage the Programs & Grants Committee (PGC) approval process; establish KOL contracts and keep records in accordance with DS policies and procedures.</li><li>Conduct other projects as assigned within, or by, Global Project Management & Leadership group.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>High School Diploma Bachelor's Degree or a related area is preferred, or equivalent years of work-related experience considered in lieu of a degree required</li></ul>Experience:<ul><li>7 or More Years 8+ years of prior experience as a project administrator or similar role in a pharmaceutical drug development environment required</li></ul>Travel:<ul><li>Ability to travel up to 5%</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Meetings & Project Support Associate, Global Project Management

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities:<ul><li>Represents the assigned products to health care professionals in assigned sales territory.</li><li>Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers.</li><li>Develop and execute comprehensive business plans.</li><li>Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patient flow/influence between academic institutions, hospitals, and community practices).</li><li>Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient treatment.</li><li>Analyze customer needs and interests, territory performance, program outcomes, and business trends; develop and execute business plans that optimize the commercial potential of our products.</li><li>Maintain expert understanding of the relevant disease state(s), assigned Daiichi Sankyo brands, and competitor products.</li><li>Completes all assigned training.</li><li>Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts.</li><li>Communicates on a regular basis with District Manager, internal and co-promote peers and discuss issues and opportunities.</li><li>Builds relationships with Daiichi Sankyo customer base and key opinion leaders. Communicates products approved indications, features and benefits in both individual and group settings.</li><li>Meet all administrative expectations and standards, including budgets, reporting, and communication.</li><li>Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals.</li><li>Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals.</li><li>Submits completed reports on-time, and communicates matters that are relevant to the marketplace to the District Manager.</li><li>Maintains all equipment and territorial records in the prescribed manner.</li><li>Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management.</li><li>Adhere to compliance and operating principles and expectations.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university):<ul><li>Bachelor's Degree required</li></ul>Experience Qualifications:<ul><li>4 or More Years of sales/marketing experience in the pharmaceutical or medical industry required</li><li>4 or More Years of oncology therapeutic experience strongly preferred</li><li>1 or More Years additional therapeutic experience in diverse roles - training, marketing, market access preferred</li><li>Oncology product launch experience preferred</li><li>Copromotion experience a plus</li><li>Strong verbal and written communications skills</li><li>Proficiency in MS Word, Excel, PowerPoint and Outlook</li><li>Must be able to travel approximately 40% to 60%</li><li>Must have a valid driver's license with a driving record that meets company</li><li>Compensation and seniority level/title based on experience and qualifications</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $148,480.00 - $222,720.00 Download Our Benefits Summary PDF

Oncology Territory Manager, Breast - Winston Salem, NC

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities:<ul><li>Represents the assigned products to health care professionals in assigned sales territory.</li><li>Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers.</li><li>Develop and execute comprehensive business plans.</li><li>Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patientflow/influence between academic institutions, hospitals, and community practices).</li><li>Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient treatment.</li><li>Analyze customer needs and interests, territory performance, program outcomes, and business trends; develop and execute business plans that optimize the commercial potential of our products.</li><li>Maintain expert understanding of the relevant disease state(s), assigned Daiichi Sankyo brands, and competitor products.</li><li>Completes all assigned training.</li><li>Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts.</li><li>Communicates on a regular basis with District Manager, internal and co-promote peers and discuss issues and opportunities.</li><li>Builds relationships with Daiichi Sankyo customer base and key opinion leaders. Communicates products approved indications, features and benefits in both individual and group settings.</li><li>Meet all administrative expectations and standards, including budgets, reporting, and communication.</li><li>Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals.</li><li>Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals.</li><li>Submits completed reports on-time, and communicates matters that are relevant to the marketplace to the District Manager.</li><li>Maintains all equipment and territorial records in the prescribed manner.</li><li>Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management.</li><li>Adhere to compliance and operating principles and expectations.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university):<ul><li>Bachelor's Degree required</li></ul>Experience Qualifications:<ul><li>4 or More Years of sales/marketing experience in the pharmaceutical or medical industry required</li><li>4 or More Years of oncology therapeutic experience strongly preferred</li><li>1 or More Years additional therapeutic experience in diverse roles - training, marketing, market access preferred</li><li>Oncology product launch experience preferred</li><li>Copromotion experience a plus</li><li>Strong verbal and written communications skills</li><li>Proficiency in MS Word, Excel, PowerPoint and Outlook</li><li>Must be able to travel approximately 40% to 60%</li><li>Must have a valid driver's license with a driving record that meets company</li><li>Compensation and seniority level/title based on experience and qualifications</li></ul> In compliance with New York State Pay Transparency Law, the targeted base salary range for this position is $160,000 - $190,000. Please note, actual Compensation and seniority level/title will be determined based on experience and qualifications. Additionally, this position will be eligible for sales incentive and long term incentive based on performance. This position is also eligible for a company vehicle. Our benefits are part of what makes Daiichi Sankyo, Inc. a great place to work. We are proud of our longstanding commitment to the health and well-being of our employees and their families. We provide comprehensive health care benefits at a reasonable cost that are highly competitive in the pharmaceutical industry, as well as a Savings & Retirement Plan that includes a competitive company match plus retirement account deposits. To learn more about our benefits, please view the following link: https://careers.dsi.com/en-US/page/benefits Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Oncology Territory Manager, Lung - Manhattan N

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Regulated Implementation Services Lead plays a key role in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the methodology, approach, and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional Global DX teams to ensure seamless, compliant service delivery and oversees resource planning for GDX global and regional projects requiring Validation services and Technical Lead assignments. Responsibilities<ul><li>Oversee and manage a team of Validation Leads and Technical Leads to ensure validation and technical implementation align with business priorities, GxP regulations (e.g., Part 11), laws (e.g., GDPR), and DS standards (e.g., SDLC, CSV).</li><li>Drive continuous improvement by applying expertise in GAMP5, Good Practices Guides, and RBA/CSA methodologies to ensure compliance and inspection readiness.</li><li>Stay current with emerging technologies and industry trends; lead feasibility studies, prototype development, and advocate for scalable, compliant architecture and design.</li><li>Collaborate with global quality, IT, and business leaders to align deliverables with strategic goals and regulatory requirements; drive improvements via KPIs, SDLC lessons learned, and best practices.</li><li>Serve as the escalation point for critical issues; act as a liaison between technical teams, validation teams, and stakeholders to ensure alignment on priorities and requirements.</li><li>Oversee resource planning for global and regional DX projects, strategically assigning Validation services and Technical Leads based on needs, capacity, and skillsets.</li><li>Demonstrate deep expertise in GxP regulations and validation standards (e.g., 21 CFR Part 11, Annex 11); possess a strong understanding of IT system architecture and cloud-based environments.</li><li>Manage third-party vendors, system providers, and validation partners to ensure compliance, contract fulfillment, and service excellence.</li><li>Oversee global project budgets to ensure cost-effective solutions that meet compliance and technical standards; drive vendor assessments, audits, and performance evaluations.</li></ul>Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education (from an accredited college or university)<ul><li>Bachelor's Degree in Computer Science, Life Science, Engineering, Information Technology, or related field - Required </li><li>Master's Degree in Computer Science, Life Science, Engineering, or Information Systems - Preferred </li></ul>Experience<ul><li>10+ years of experience in GxP-regulated IT system implementation, validation, and compliance in pharma/biotech/medical device industry - Required </li><li>4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required </li><li>7+ years of strong expertise in GxP regulations, CSV, 21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required </li><li>Deep understanding of IT system architecture, cloud solutions, integrations, and cybersecurity in regulated environments - Preferred </li><li>Strong strategic thinking, decision-making, and leadership skills - Preferred </li><li>In-depth knowledge of GxP application solutions and regulatory compliance</li><li>Proven ability to manage and deliver complex projects using SDLC in regulated environments</li><li>Experience in digital transformation, process improvement, and operational excellence</li><li>Skilled at leading global, cross-functional teams with strong relationship-building skills</li><li>Excellent communication, listening, and stakeholder engagement skills</li><li>Strong analytical, organizational, and time management capabilities</li><li>Proficient in Microsoft Office Suite (Word, Excel, Access, Visio, PowerPoint, Project); familiarity with pharma business applications</li><li>Customer-centric mindset with the ability to multitask in a dynamic, fast-paced environment</li></ul>Travel Requirements<ul><li>Ability to travel up to 10%</li><li>Travel includes visits to DSE, DSJ locations, including international travel to the US, EU, and Japan</li></ul>Equal Opportunity Employer Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Regulatory Implementation Services Lead

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders Job Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (e.g., Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes, procedural documents and supporting job aids up to date, and to facilitate the use of effective, harmonized processes globally. This role will be responsible for coordinating the authoring, review and approval of new or updated procedural documentation. In addition, this role will work closely with process owners, subject matter experts (SMEs) and Quality colleagues within R&D and cross-functionally, to facilitate, roll-out and track just-in-time, role-based training, as processes and ways of working are revised. He/she may also serve as a key regional point of contact for cross-functional process and procedural document related questions. The individual in this role will also be responsible for overseeing inspection readiness and supporting internal audits and Health Authority (HA) inspections. For any non-compliances / potential non-compliances identified, this role will be responsible for conducting root cause analyses, documenting/tracking associated CAPAs or process deviations, and coordinating the end-to-end management of these. They will also be responsible for conducting proactive risk assessments related to regulatory processes on a consistent basis and identifying areas of potential non-compliance or operational risks. Responsibilities:<ul><li>Maintain regulatory procedural documentation, in line with company-wide policy and relevant regulatory requirements</li><li>Coordinate with broader DS quality teams to support GRA meeting company policies for quality management (e.g., completing requests/initiatives from the GSOP Committee)</li><li>Proactively manage required periodic review for controlled procedures</li><li>Ensure global and cross-functional consistency of process documentation to the extent possible by coordinating reviews and updates with relevant process owners / SMEs</li><li>Monitor key GRA process performance / adherence / metrics to proactively address operational risks</li><li>Serve as a regional Process expert regarding maintaining a compliant set of procedural documents</li><li>Work with RA and cross-functional stakeholders to update processes and procedural documentation, define metrics/KPIs and coordinate training for teams</li><li>Coordinate redesign/update of key processes and associated documentation as necessary; this may include facilitating cross-functional meetings to align on process changes and coordinating timelines and responsibilities for authoring, review and approval of procedural documents</li><li>Serve as a facilitator for process updates that may include new ways of working with existing or new systems (e.g., Vault RIM)</li><li>Work with GRA stakeholders to define appropriate KPIs/metrics to track process compliance, performance and adherence</li><li>Work with the data/systems SMEs to define reporting needs to oversee process performance</li><li>Share and review data/metrics with the GRA Analytics Team</li><li>Coordinate the development and roll-out of training for changes to processes / ways of working</li><li>Support Regional and Functional Leads in management of Role Based Curriculums</li><li>Drive continuous improvement of GRA processes and ways of working</li><li>Drive activities required for GRA to be inspection ready, and support addressing any observations or findings that may result from audits and inspections</li><li>Work with QA to understand and provide input to the planned schedule internal audits and mock inspections</li><li>Support inspection readiness including maintaining access to relevant documentation / reports</li><li>Support HA inspections or internal audits as needed, coordinating with relevant process owners and cross-functional SMEs</li><li>Conduct root cause analyses for any issues identified, to define CAPAs/deviations</li><li>Maintain a GRA database for tracking process deviations / CAPAs</li><li>Coordinate activities required to resolve process deviations / CAPAs arising from either internal audit or HA inspection findings</li><li>Work with cross-functional stakeholders to enable sufficient input and buy-in being received where needed</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>Bachelor's Degree Data Science, Computer Science, Engineering, Statistics, or related field required</li></ul>Experience:<ul><li>4 or More Years Experience in quality management in the pharmaceutical industry and quality (GxP) requirements Experience with process mapping, process redesign and SOP authoring/coordination (Required)</li><li>3 or more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (e.g., ICH, FDA, EMA) (Required)</li><li>2 or more years with experience working with international teams; strong understanding of cross-cultural environments and different business practices across key markets (Required)</li><li>2 or more years with experience coordinating and managing regulatory audits and inspections, incl. CAPA management (Prefered).</li></ul>Travel: <ul><li>Ability to travel up to 10% Business travel</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Regulatory Process Excellence Manager

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position is responsible for the administration and operational support of Daiichi Sankyo's Veeva CRM system within IT. They'll collaborate with various sales and marketing customers to identify new and support existing CRM functionality. Primary responsibility will be around supporting our Omnichannel Marketing customers related to various CRM functionality such as Suggestions, Next Best Action, Integrated Scheduling, CLM, Rep Triggered E-mails, etc. They'll also collaborate closely with internal IT stakeholders and various external vendors to deliver solutions. Responsibilities - Business Analysis: Analyze sales and marketing business requirements and translate them into functional specifications for Veeva CRM. Collaborate with business stakeholders to gather and document business needs, objectives, and processes related to Veeva CRM as it pertains to Omnichannel Marketing Team and Other Sales related functions. - Implementation: Identify opportunities for process improvement and recommend solutions to enhance the functionality and effectiveness of Veeva CRM and Omnichannel Marketing processes. Provide technical expertise related to the configuration of Veeva CRM and perform data analysis and configuration deliverables related to business processes. Conduct user acceptance testing and provide training and support to end users. Participate with internal IT data teams/vendors to understand data integrations and API requirements (no development experience required) in and out of Veeva CRM system. - Documentation: Document various system related documentations such as system configurations, data flow processes, test scripts, functional specification, training documentation, etc. Ensure document integrity and version control by leveraging SharePoint and/or other M365 features. - Ongoing Support: Develop and maintain a deep understanding of Veeva CRM and Omnichannel Marketing capabilities and best practices. Responsible for system administration of Veeva CRM. Troubleshoot and resolve issues related to Veeva CRM and Omnichannel Marketing functionality, data integrity, and system performance. Stay up-to-date with industry trends and advancements in Veeva CRM and Omnichannel Marketing and provide recommendations for system enhancements and upgrades. Stay on top of new upgrade releases in Veeva CRM and partner with customer to evaluate and implement as needed. Responsible for the Help Desk operational guidance and support related to application tickets, setting and monitoring SLAs, coordinating training, and remediating User issues. Provide support across all areas of CRM system development lifecycle (SDLC) including creating training documentation for all supported applications. - Collaboration: Attend customer facing meetings to communicate standards and directions, as well as advise on technology solutions and capabilities in CRM. Collaborate with external technology vendors and internal IT teams to ensure the successful integration of Veeva CRM and Omnichannel Marketing features with other systems and applications such as C360, data warehouse, marketing cloud, etc. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Bachelor's Degree in Information Systems, Computer Science or business related discipline required required Experience Qualifications - 1 or More Years Experience 2 years of proven hands-on experience administering, configuring, and supporting Veeva CRM (CLM, Engage, Approved E-mails, MyInsights) and other modules of CRM required. required - 1 or More Years Strong understanding of pharmaceutical and life sciences industry processes and regulations preferred. - 1 or More Years Proficient in business analysis, process mapping, and functional requirements gathering preferred - Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams internally and externally. preferred - Strong problem-solving and analytical thinking abilities. preferred - Ability to manage multiple priorities and meet deadlines in a fast-paced environment. preferred - Veeva CRM or Veeva Vault certifications are preferred. preferred - Knowledge of ITIL processes (Incident Management, Change Management and Problem Management) and Service Management principles preferred. preferred Travel Ability: to travel up to 5% Attend minimal industry and DSI sponsored events Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Senior Analyst - Veeva CRM

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This is an operational position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if outside of scope of role, and/or complexity. This position has strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time. Has sufficient knowledge to identify critical issues or problems with projects and/or identification of issues which may compromise patient dosing or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized and the need for CAPAs or reports on deviations is clearly understood. Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences exist and understanding of the need to address such issues or concerns. Experience with IRT systems and support in managing the forecasting and planning of drug supply needs. Can participate effectively on a cross functional and on Global teams. Responsibilities:<ul><li>Works, under supervision, with outsourcing to submit appropriate requirements on a project basis. Supports team in generating RFPs and in reviewing proposals and selecting vendors. This position also supports the management of the WO development and implementation.</li><li>Supports packaging design and patient kit supply preparation, label generations and approvals and associated interactions with vendors. Supports regular vendor/sponsor discussions to identify risks and ongoing study support. Identifies critical issues which may compromise patient dosing or safety. Supports comparator sourcing requirements, RFP generation and working with outsourcing to submit appropriate requirements on a Project basis.</li><li>Vendor Management - support interactions with Vendors on packaging design and patient kit supply preparation, label generations and approvals. Support regular vendor/sponsor discussions to identify risks and ongoing study support.</li><li>Ensures on time site shipments for subject and patient dosing, and ensures that material is fully released prior to shipment to site</li><li>Ensures compliance with all domestic and foreign regulatory requirements but may seek line management support when necessary. Basic knowledge of Import/export requirements to the extent that there is overall recognition of potential global issues as regards import license requirements, shipment delays and is able to communicate the issues and support resolution development.</li><li>Support IRT design for control of drug dispensing and inventory management. Understand User specifications in support of IRT processes and basic concepts of IRT</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) <ul><li>Bachelor's Degree required</li><li>Master's Degree preferred</li></ul> Experience Qualifications <ul><li>4 or More Years related professional experience required.</li><li>Must have professional experience Project Management, Clinical Supply Management, and/or Clinical Trials Coordination</li><li>Demonstrated experience in working in any of these areas: inventory management, forecasting, and distribution of drug supply needs, IXRS experience, managing vendors and contributing to budget control preferred</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Senior Associate SP&L

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SUMMARY The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Development Sankyo's development compounds through the Safety Management Team framework. This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization). RESPONSIBILITIES<ul><li>Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.</li><li>Effectively represent the CSPV on the Global Product Team or other cross-functional teams providing the safety leadership and serving as the primary point of contact.</li><li>Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals.</li><li>Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.</li><li>Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle.</li><li>Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time.</li><li>Coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments).</li></ul>QUALIFICATIONS Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>MD Board certification or eligibility required</li></ul>Basic Requirements<ul><li>6 or more years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.</li><li>Expertise in oncology highly preferred.</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $269,850.00 - $449,750.00 Download Our Benefits Summary PDF

Senior Director, Clinical Safety MD

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The purpose of the Senior Director, Forecasting & Business Analytics is to lead the forecasting and financial and analytical support of commercial assets. In addition, this role will lead the forecasting process supporting the Business Development team through financial analysis and valuation process for investment and other business development opportunities. This position will own the revenue and contract analytics forecasting process, as well as financial business development valuations in order to provide strategic guidance to senior management, support commercial and strategic decision making. Responsibilities<ul><li>Revenue Forecasting - Owns the revenue forecasting process for all in line and pre-launch US products, both oncology and non-oncology. Leads the team to develop sophisticated short-term and mid-term sales forecasts for in-line and pre-launch products, providing strategic guidance on commercial and alliance partnership decisions as well as supply chain inventory. Ensures communication and alignment with finance colleagues as well as Global Business Strategy and Analytics. Acts as a trusted thought leader for the organization who provides strategic guidance and data-driven insights. Collaborates with and influences franchise teams and other cross-functional stakeholders around the latest thinking on forecast assumptions such as launch timing, market insights and competitor entrants. Manages forecast alignment discussions between DS business units and alliance counterparts, as well as US franchise leadership and Corporate Planning Team in Tokyo, focusing on assumptions, revenue drivers, opportunities and risks. This position will ensure that the team follows the established Revenue forecasting process, puts into effect governance and controls steps to safeguard the integrity of the process and facilitate process improvement.</li><li>People Leadership - Coach, motivate, and develop staff to ensure high degree of service is maintained and staff remains focused on corporate goals and maintains a high level of engagement. Direct staffs to maintain high involvement with business partners in order to continue learn the competitive environment, therapeutic areas, etc. and become true business advisors to the commercial teams and continue to develop ability to clearly communicate across the organization.</li><li>G2N Forecasting - Oversee the G2N Contract Forecasting to ensure support of cross-functional teams regarding key managed care accounts and ASP analysis. This includes: profitability analysis of current contracts, sensitivity analysis of the impact of access strategy on the business, impacts of changes in contracts terms, and pricing actions on net revenue. This individual is responsible for ensuring tools, data and models are in place to meet reporting/analytical needs for G2N.</li><li>Business Development Support - Direct the financial analysis and valuation process for business development, licensing and collaboration investments. Partner with Global Business Development and Commercial teams to understand strategic fit of the investment opportunity and to align on the forecast and valuation assumptions. Lead financial and due diligence efforts and ensure tax collaboration: work directly with the BD project lead as well as legal team to proactively inform them of the timelines and efforts required to complete due diligence. Assess the need and engage consultants as necessary and facilitate communication among different parties.</li><li>Business Partnership - Develop business partnership with key stakeholders across the business and alliance partners. Deliver clear storyline of technical forecast assumptions to partners and collaborators, ensuring their understanding and alignment with assumptions and related impacts. Keep up to date with changes in the business and communicate potential impacts of those changes.</li><li>Change Management - Continuously review the financial procedures and drive new processes and/or system enhancements to improve organizational efficiency while ensuring accuracy and process controls are not compromised.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree preferably Finance, Accounting, Economics required</li><li>MBA other advanced degrees preferred Experience Qualifications</li></ul><ul><li>10 or More Years of commensurate experience in financial analysis and forecasting; required</li><li>Pharma Brand Finance or Forecasting experience preferred</li><li>Deep knowledge of therapeutic areas that DSI competes in or demonstrated ability to develop that knowledge; preferred</li><li>Detailed knowledge of all channels of managed care environment in the US (commercial, Medicare, Medicaid, etc.); preferred</li><li>Sufficient understanding of financial matters to challenge and pressure-test assumptions (e.g. pricing, GTN, etc.). preferred</li></ul>Trave lAbility: to travel up to 10% | Some limited travel for meetings and/or conferences. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $214,050.00 - $356,750.00 Download Our Benefits Summary PDF

Senior Director, Forecasting and Business Analytics

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable for innovation, standards, processes and infrastructure in RBQM. Accountable for selection and oversight of external vendors within technical scope. Will also be responsible for the internalization and oversight of the RBQM model. Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for the management, performance, and development, both technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface with technical teams in other functions to triage monitoring or other actions with the investigational sites. Additionally, this position possesses adequate knowledge of drug development in pharmaceutical industry across different disease areas, and the ability to determine risk factors with and for other technical departments (eg, Clinical, Medical, Safety, Data Management, Statistics). This position requires skills in working in a fast-paced environment, continuous improvement, change management, and risk management. Experience working and managing CROs in the RBQM space is also required. Responsibilities: - Group strategy: Sets the vision and strategy for the group including overall vision for a robust risk assessment, mitigation, central (statistical) monitoring and signal detection. Identifies areas to be improved and initiates rectification or remedial activities. Develops the strategy for technology and innovation to improve the overall efficiency in project execution and deliverables. Oversees or initiates RBQM operating procedures and standards; monitors and enforces compliance of standard procedures and processes. Proactively manages resource planning to ensure adequate resources are available to business priorities. - RBQM Strategy: Establishes and drives standard RBQM strategy, provides strategic or tactical input to the RBQM projects. Communicates and collaborates with other function leaders during this process to support decision making and execution. Develops overall outsourcing strategy for the function including internalization strategy and execution plan. Responsible for developing, implementing, and maintaining the plan to internalize RBQM efforts while overseeing the 3-way model for ongoing/near term new trials. - External Vendor Oversight: Manages higher-level negotiation with external vendors. Provides oversight of quality/performance and budget, resources and timelines across the department and ensures timely delivery of high-quality deliverables at reasonable cost. Provides documented oversight of the external vendors/sponsor partnership under the RD-wide vendor oversight structure. Strategically leverages external expertise in supporting RBQM activities. - Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality factors, select critical variables and processes, and build appropriate mitigations. Drive interface with Integrated Data Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics including Quality Tolerance Intervals, Key Risk Indicators, Key Performance Indicators, and grouped variables for signal detection. Articulate to Study Team for appropriate site and study level triage, actions, and rectifications. - Deliverables: Working with RBQM leaders to provide oversight of activities performed by the internal RBQM function in association with other DS functions, or any vendor outsourced roles on RBQM behalf. Advises, directs, prioritizes, and monitors all RBQM activities and deliverables in terms of timeline and quality. - People Management Leadership: Accountable for the management, development, recruitment and training of employees within the departmental scope to meet current and future business needs. Provides exceptional leadership to employees within responsible areas. Leads coaching and development of employees across the function. Provides leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. Manages and provides guidance to team members, including organizing and prioritizing group tasks, performing training, and managing performance. Responsible to create an environment where employees feel engaged and empowered, and take pride in their roles, responsibilities, and deliverables. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Master's degree in life sciences, data science, statistics, or related field required - PhD in life sciences, data science, statistics, or related field preferred Experience Qualifications: - 11 or more years of experience in RBQM and/or related work experience in pharmaceutical company, Biotech, or similar environment (e.g., CRO). required - 5 or more years managing people required - 5 or more years managing projects required Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $206,025.00 - $343,375.00 Download Our Benefits Summary PDF

Senior Director, Head of RBQM

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts with a comprehensive and all-encompassing approach to coordinate activities, under the leadership of the Head of Functional Excellence, across key functions to improve the benefit-risk in patients treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role, the incumbent will contribute to creation and improvement of Clinical Development processes. Job Description: <ul><li> Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non-clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting. </li><li> Responsible for the execution of key safety initiatives aimed at preventing, mitigating, and addressing critical safety issues including but not limited to protocol amendments, Dear HCP letters and key medical education initiatives.</li><li> Develops prospective contingency plans for management of assigned safety risks across projects; Clearly defines priorities and high-level execution plans across and effective alignment within (e.g. with translational research, clinical operations, clinical development, medical affairs CSPV and other internal groups) and outside of Daiichi Sankyo (e.g. clinical trial sites, CROs, collaboration partners); Supports effective direct communication with clinical sites in collaboration with clinical development staff. </li><li> Consults with KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub- PI's, nurses) at the site level to ensure that patient safety with respect to the safety risk assigned remains top of mind in the context of patient management in the clinical trial setting and in the real-world setting. </li><li> Contributes to creation and improvement of Clinical Development processes.</li></ul> Education: <ul><li> MD required; prefer Board certification in Oncology.</li></ul> Experience: <ul><li> At least 7 years of experience in pharmaceutical industry. </li><li> At least 2 years in Patient Safety. </li><li> At least 2 years of experience in Clinical Development. </li><li> At least 2 years of Oncology experience. </li></ul> Competencies: <ul><li> An impeccable oncology clinical and medical expert with proven credibility and experienced in patient safety and clinical development.</li><li> Experience working in a matrix environment and on cross-functional teams. </li></ul> Travel: <ul><li> Local and global travel might be required up to 20% </li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Senior Director, Oncology R&D Functional Excellence

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This position manages multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves as ad hoc member to the Global Project Team for late stage projects. This position manages multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO. This position develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (e.g., IND, IMPD, IB) and marketing applications/supplements & variations (e.g., NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this position acts as the company liaison with the Health Authority (e.g., US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (e.g., preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from preparation of the briefing book, to training and preparing the technical team, to authoring and finalizing the meeting minutes. This position develops awareness of global requirements through support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence, regulatory authority inspections). Additionally, this position has direct interaction with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some complexity. This position makes decisions with consultation. Responsibilities:<ul><li>Planning for Development : Manages multiple CMC development projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.</li></ul><ul><li>Execution of Strategy and Submissions: Develops strategy with supervision. Prepares content templates and leads technical team in preparation of submission documents; authors regulatory documents where necessary with supervision.</li></ul><ul><li>Health Authority Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager.</li></ul><ul><li>Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company initiatives.</li></ul>Qualifications: Education and Experience: <ul><li>Bachelor's Degree in Life Science required.</li><li>M.S./PhD. preferred in a scientific discipline. </li><li>MS Degree with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or</li><li>PhD. with 6-8 years pharmaceutical industry experience and 4+ years direct or related CMC regulatory experience</li><li>Successful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA</li></ul> Competencies: <ul><li>Advanced knowledge of regulations/guidance documents with strong technical knowledge based upon academic training and job experience.</li><li>Strong oral and writing skill. Able to write regulatory documents in highly complex technical areas.</li><li>Ability to travel up to 10%, Global Travel</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Senior Scientist/Associate Director, Regulatory Affairs CMC

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