Learn more about free job search tools, learning opportunities, and exclusive member events.

Discover CareerCircle

Access resources to advance your job search and career growth.

Tools & Training

Explore a wide range of job opportunities that match your skills and career goals.

Search Jobs

Create a professional resume that captures the attention of top employers with our easy-to-use tool.

Resume Builder

Prepare for your next interview with our expert tips and strategies.

Interview Prep

Discover in-depth profiles of leading employers to find your ideal workplace.

Search Companies

Develop in-demand skills with curated courses for today’s job market.

Courses

Access career resources and job postings anytime, anywhere with our app.

Mobile App

Source skilled talent and build your team.

Talent Acquisition

Access skilled talent ready to excel via our AI-driven platform, virtual events, and recruitment services.

CareerCircle TalentConnect

Transform your workforce and hiring practices with essential training and continuing education.

InclusiveU

Broaden your talent pool with dedicated support for individuals with disabilities.

Getting Hired Powered by CareerCircle

Mission aligned solutions supporting Non-Profit Organizations, Educational Institutions, Local Workforce Development Boards, and Learning Providers.

Upskilling & Job Advocacy

Upskilling solutions designed to empower members with in-demand skills training and ongoing support for successful certificate completion.

CareerReady

Job advocacy solutions to connect job seekers to inclusive employers through dedicated recruiting support.

CareerAdvocacy

Learn how we connect all communities with careers and build skilled talent pipelines.

About CareerCircle

Discover answers to common questions and gain insights into our goals and services.

Reach out to us for inquiries, support, or to learn more about our mission and services.

Contact

Explore our blog for latest news and trends for job seekers and employers.

Blog

Access our virtual career fairs, job seeker workshops, and employer focused webinars.

Events

Discover valuable resources to enhance your hiring strategy and drive organizational success.

Employer Resources

Get the latest news and updates on our mission, partnerships, and community impact.

Press Room

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Clinical Study Manager is responsible for the delivery and execution of global clinical studies under the direction of a Study Delivery Lead. This role is primarily focused on tactical study delivery and reports to a Director or higher-level position. The position requires excellent written and verbal communication, project management skills, and attention to detail. The Clinical Study Manager will have routine interaction with key internal and external stakeholders to communicate project status, resolve issues, and troubleshoot routine inquiries. This position may require the Clinical Study Manager to take on a dual role of both operational strategy and study execution. Job Description Responsibilities Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables. In a CRO outsourcing model, responsibilities also include: <ul> <li>Study Oversight: Lead the clinical study operational aspects of planning, execution, and management of one or more Phase 1-3 clinical trials. May provide support as back-up to the Study Delivery Lead as needed.</li> <li>Cross-Functional Leadership: Participate and provide expertise as a cross-functional study team member, including vendors, and liaise with other departments. Provide mentorship of more junior Operations team members.</li> <li>Vendor Management: Lead vendor selection, contracting, and management to maintain study quality and compliance and adherence to scope of work within timelines and budget. Oversee complex vendors (i.e., eCOA).</li> <li>CRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level. Coordinate and develop materials for CRO KOMs and Investigator meetings.</li> <li>Compliance and Regulatory: Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.).</li> <li>Timeline and Budget Management: Create and coordinate clinical study timelines and budgets with Global Project Management and R&D Finance to meet critical milestones and manage budgets. Responsible for continual review of study timelines and study budget.</li> <li>Risk Management: Identify, mitigate, and escalate risks per process throughout the study lifecycle. Ensure risks are appropriately logged in the risk management system.</li> <li>Study Material Development: Co-develop and manage study materials, including training materials, protocols, CRFs, and study operational plans. Ensure all necessary operational materials are in place.</li> <li>Data Cleaning: Oversee site and monitor data cleaning metrics including EDC data entry, query resolution timeliness, and protocol deviation review.</li> <li>Site Management: Oversee site selection, start-up, monitoring, and closeout for the trial.</li> <li>Study Communication: Triage, resolve or escalate study issues /risk mitigations to the Study Delivery Lead.</li> <li>Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).). oSupports risk Management initiatives oSupports audit/inspection activities as needed oEnsures trial master file is complete and accurate for assigned stud(ies)</li> <li>Communication and Reporting: Provide regular updates on study progress to key stakeholders.</li> <li>Training: Identify training needs for key stakeholders as needed, e.g., study team members, vendors and ensure training is carried out. Develop training materials as necessary.</li> </ul>Responsibilities Continued Qualifications Education Qualifications Bachelor&apos;s Degree preferred in Life Sciences required Experience Qualifications 3 or more years required and Relevant experience is required with a BSc required and Experience in oversight of global clinical trials (all phases) in all stages of delivery with requisite industry training and experience required and Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). preferred CRA experience preferred Time spent directly in a medical environment (e.g. as a Study Site Coordinator) preferred Familiarity to a Japan-based organization preferred Travel Requirements Ability to travel up to 10% of the time. In-house office position that may require occasional travel (domestic or global). Additional Information 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: USD$133.600,00 - USD$200.400,00 Download Our Benefits Summary PDF

public

Clinical Study Manager, Global Clinical Operations - 30014765

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job 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>Achieves or exceeds sales objectives through promotion of product features and benefits to our key accounts: Academic Institutions, Hospitals, Infusion Centers, Hematologists, Hospitalist, Bone Marrow Transplant members, buying groups, distributors and wholesalers in assigned territory.</li><li>Builds relationships with our customer base and key opinion leaders by personally visiting them, educating and influencing physicians and healthcare providers to prescribe Daiichi Sankyo, Inc.'s promoted products. Communicates in a fair and balanced way, products&apos; approved indications, advantages, features and benefits in both individual and group settings.</li><li>Analyzes customer needs and interests. Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals. Carries out all sales and marketing programs. Maintains frequent correspondence with District Manager, co-promotion team members, CARE team members and counterparts across the district and region.</li><li>Complies with applicable laws in providing healthcare providers with accurate information concerning Daiichi Sankyo, Inc.'s products.</li><li>Participates in assigned training and completing outside reading. Keeps abreast of the products, applications, technical service, market conditions, competitive activities, advertising, and promotional trends through the reading of pertinent literature and consulting with colleagues. Attends and participates in all required meetings and training programs.</li><li>Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts.</li><li>Maintains all equipment and territorial records in the prescribed manner. Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management. Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals. Submits complete reports, on-time, and communicates matters that are relevant to the marketplace, competition and the marketing team to the District Manager.</li><li>Notifies the Medical Affairs Pharmacovigilance immediately of any product complaints as per SOP 805.21, Reporting Adverse Events (AEs) and Product Quality Complaints (PQCs).'</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&apos;s Degree required</li></ul>Experience Qualifications:<ul><li>4 or More Years overall pharma or healthcare related experience required</li><li>1 or More Years sales/marketing experience in the pharmaceutical or medical industry required</li><li>specialty, rare disease, and/or oncology experience strongly preferred</li><li>experience selling in complex environments preferred</li></ul>Additional Qualifications: <ul><li>Must be able to travel up to 60%</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 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: USD$139,440.00 - USD$209,160.00 Download Our Benefits Summary PDF

Oncology Territory Manager, Hematology - Pittsburgh

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Associate Director, QMS Training Management (Global R&D & PV QA) reports to the Head Global Quality Management System (QMS) (Americas/Europe) and is responsible for managing and supporting the implementation of the global GCP/GVP/GLP training and onboarding strategy, training development and delivery, and measuring training effectiveness and compliance. The Associate Director will play a global training lead role in supporting the global R&D, PV, MA, and QA organizations to ensure the GCP/GVP/GLP training and communication strategies, processes, procedures, programs, and systems comply with applicable GCP/GVP/GLP standards, relevant regulatory requirements, and applicable Daiichi Sankyo policies and procedures. Job Description Training Program Management: Manage the creation and implementation of training courses as identified in annual training plans, role-based training curricula, GCP/GVP/GLP computer systems training plans, and other projects as needed in collaboration with functional leaders, SMEs/SOP authors, training vendors, and regional/local training leads. Assess training needs and determine optimal training delivery approach, training audience, and communication strategy in a training implementation plan with global/local training leads, SMEs/SOP Authors Facilitate identifying training content for development and delivery with functional leaders and SMEs/SOP Authors. Oversee/manage the creation of training courses in various modalities, including blended approaches (e.g., instructor-led training, eLearning, etc.) with SMEs/SOP Authors, vendors. Engage with and manage external training vendors as required to ensure training content availability and delivery. Create, implement, and maintain the global GCP/GVP/GLP New Employee Onboarding program that ensures effective functional onboarding of GCP/GVP/GLP resources by partnering with functional leaders and representatives. Oversee/manage the global and local learning management system activities, including role-based training curricula development and administration, training and roster registration/assignment, course creation and availability, and training histories. Qualify GCP/GVP/GLP SMEs identified to deliver instructional design/adult learning principles training by implementing the SME Train-the-Trainer qualification program. Stay current with industry-leading training practices and incorporate them into GCP/GVP/GLP training. Partner with Global QA leaders, functional leaders, or their SMEs to incorporate CAPAs and lessons learned into training activities. Qualifications Education <ul><li> A Bachelor's Degree in a science-related discipline required. A higher-level degree such as a Master's Degree is preferred </li></ul> Basic Requirements 7 or more years of professional pharmaceutical industry experience managing GxP learning development activities in the pharmaceutical or biotech industry, or equivalent experience is required. Must have in-depth knowledge of Quality Management Systems and related GxP principles: Broad understanding of global expectations of Regulatory Health Authorities Extensive knowledge with managing global Training Programs, Development, Implementation, Management, including System management application Strong interpersonal and prioritization skills with demonstrated ability to build collaborative relationships Excellent problem solving and decision-making skills. Skilled at conflict resolution / negotiation. Organization awareness (e.g., interrelationship of depts., business priorities), including significant experience working cross-functionally and in global teams across different regions of the world Experience with participation in regulatory inspections presenting or defending subject matter area in audits or regulatory inspections. Understanding and familiarity with FDA, EMA, MHRA, and other European and international regulatory requirements, guidelines 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: USD$150.800,00 - USD$226.200,00 Download Our Benefits Summary PDF

Associate Director, QMS Training & Document Management (Global R&D & PV QA)

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary US Medical Affairs leader for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops the USOMA strategy and tactical plan as part of the US Brand Strategic Plan and leads the execution of the activities in the USOMA plan including Launch Readiness and Life Cycle Management. Leads the team for this compound. Job Description Responsibilities Responsible for the development of the USOMA strategy and medical objectives for the assigned compound and leads development and execution of the US Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective Participates in Global Medical Affairs committees as requested. Serves as US Medical Affairs Lead, to gain strategic and planning alignment across the matrix team and the core USOMA functions. Represents US medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions. Provides medical leadership: oLeads USOMA teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts as needed. Partners with RWE and HEOR strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the USOMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a US IIS Review Committee, for assigned compound. oCollaborates with Global Medical Affairs and across USOMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data. In partnership with Medical Intelligence and Congress Planning leads, communicates and educates on related competitor data. oProvides medical leadership in scientific engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key thought leaders. Provides medical support for scientific symposium and medical congresses within legal and compliance regulations. oWorks with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education strategies for independent grants, respectively. oProvides input into publication strategy, data gap analysis, and tactical planning as part of the overall USOMA plan. Reviews and approves abstracts, manuscripts, and other data disclosure documents. Attract and develop USOMA talent. Provides coaching, direction, feedback and guidance as needed. Evaluate team progress against goals/objectives. Manage budgets and resources efficiently for USOMA supported activities within the USOMA plan, is required. Experience in collaboration with US Oncology Franchise Head oncology therapeutic area is required Responsibilities Continued Qualifications Education Qualifications An advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical/ scientific area required MD preferred Experience in oncology therapeutic area required Experience Qualifications 10 or More Years Pharmaceutical industry experience or commensurate healthcare or research experience required and 4 or More Years Minimum of 5 years of (in-house) medical affairs or related experience, US preferred required and &bull; Must have oncology experience, specifically in solid tumors. &bull; Previous overall responsibility and accountability for multiple indications of one or more compounds and related USOMA plan/budget for related MA activities &bull; Demonstrated ability to lead and influence others internally and externally &bull; Experience leading matrix medical teams and representing medical on cross-functional leadership teams (e.g. US Product Team, US Brand Team, Global Medical Team, etc.) &bull; Relationships with or proven history developing key external experts &bull; Proven ability to manage multiple priorities at one time required and &bull;Knowledge of ADC or other biologics, or small molecules &bull;Demonstrated experience working with an alliance partner company preferred Travel Requirements Ability to travel up to 20% of the time. Additional Information 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: USD$230.175,00 - USD$383.625,00 Download Our Benefits Summary PDF

Senior Director, USMA Oncology

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary This position supports the Associate Director, PV Quality & Compliance, PV Quality Management in the establishment, implementation, and oversight of the CSPV Quality, Compliance and Training function. This position is responsible for managing activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance reports relative to safety reporting processes and regulatory authority submissions. This role is the primary CSPV contact for Good Clinical Practice (GCP) and Pharmacovigilance (PV) inspections conducted by global Health Authorities/Regulatory Authorities (HAs/RAs) and PV audits conducted by DS Quality Assurance and License Partners/Affiliates, as applicable. This position is responsible for facilitating audit and inspection-related activities within CSPV and supports the development of inspection readiness initiatives. This position is responsibility for identifying training needs for CSPV staff and developing and overseeing training to ensure awareness of and compliance with organizational objectives and global laws and regulatory requirements. With support from the Associate Director, PV Quality & Compliance, PV Quality Management , this position will take a lead role in the design, development, and coordination of training programs based on corporate, organizational and individual needs, collaborating with CSPV management and cross-functionally to ensure training needs are met. This position is responsible for the design and development of a procedural document management program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable. This position liaises with CSPV management and cross-functional teams as necessary throughout the corporation to drive a culture of regulatory compliance and ensure effective and efficient management of CSPV activities. Job Description Responsibilities Quality and Compliance:<ul><li>Manages activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance metrics reports relative to the safety reporting and regulatory submission of individual case safety reports (ICSRs) and aggregate periodic safety reports.</li><li>Drives and manages an effective corrective action and preventive actions (CAPA) process including but not limited to the tracking, trend analysis, root cause analysis and implementation of process improvement measures and effectiveness checks.</li><li>Leads audit/inspection readiness activities including but not limited to conducting routine/periodic quality assurance assessments to measure and ensure adherence of CSPV processes and procedures by internal personnel and external vendors.</li><li>Support conduct of inspections and audits and closely collaborate with Global GCP/PV-QA audit department in preparation of internal audits and regulatory inspections including preparation, review and provision of relevant documents; assigning roles and responsibilities for each audit/inspection.</li><li>Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses (pending and final) and resulting measures.</li><li>Collaborates with members of inspection team and other colleagues including Quality Assurance to ensure optimum responses to audit/inspection findings. </li></ul>Responsibilities Continued Training Program:<ul><li>Takes a lead role in the development and enhancement of CSPV training programs based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable. Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training.</li><li>Training Plan and Delivery: Mentors instructors, subject matter experts and supervisors in techniques and skills for conducting effective training for staff, as needed. Oversees the quality and consistency of training conducted within CSPV. Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training. Resolves and responds to training issues and questions.</li><li>Training Records and Maintenance: Monitors training compliance, and coordinates escalation of non-compliance. Works with LMS Administrator to generate/access necessary training reports and to ensure proper training documentation.</li><li>Responsible for the implementation and maintenance of the Global Training Matrix for CSPV and leading related process improvements, as necessary. Supports the annual roll-out of the Adverse Event Reporting Policy Training assigned to all company staff globally, which includes project management, facilitation of updates to the training content, evaluation of training adequacy, and appropriate distribution of training (with technical support from the LMS Administrator for LMS assignments). Ensures training processes and relevant materials are up-to-date. May participate in creation, review, and revisions to controlled documents and procedures.</li></ul>Procedural Document Management:<ul><li>Procedural Document Program: Takes a lead role in the development and enhancement of a procedural and standards program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable. Drives the strategic direction for documentation control including retirement schedules, file structures, delivery mechanisms (instructional, LMS, etc.). Coordinates training curriculum for each function within CSPV and ensures the appropriate documentation is contained within the training profile.</li><li>Procedural Document Development and Delivery: Takes a lead role in the development of CSPV-related policies, procedures, operating guidelines including but not limited to SOPs, SOIs, guidance documents, associated forms and templates). Works closely with CSPV management, SMEs and other functions as applicable to develop SOPs, SOIs and Guidance Documents. Strives to ensure the process is optimized for efficiency and clarity. Supports process redesign initiatives by updating relevant documentation for changes to processes.</li><li>Procedural Document Records and Maintenance: Maintains all documentation files, including forms and templates and communicates updates/revisions to documents. Responsible for inspection readiness activities related to documentation. Supports all internal and external partner audits for documentation requirements.</li></ul>Qualifications Education Qualifications<ul><li>Bachelor&apos;s Degree, preferably in healthcare or life sciences, required</li><li>Master&apos;s Degree, PharmD, RN preferred</li></ul>Experience Qualifications<ul><li>4+ years of Pharmacovigilance experience in a pharmaceutical, biotechnology or related environment required.</li><li>7+ years total pharmaceutical industry experience in one or more of the following areas: Drug Safety/Pharmacovigilance, Epidemiology, and Clinical Development preferred</li><li>4+ years of direct experience in Pharmacovigilance Compliance, global setting preferred</li><li>Possesses strong knowledge of Food and Drug Administration (FDA), European Union (EU), and International Conference on Harmonization (ICH) guidelines 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: USD$124.960,00 - USD$187.440,00 Download Our Benefits Summary PDF

Manager, PV Quality Management

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job 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></ul>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. 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 Education Qualifications<ul><li>Bachelor&apos;s Degree required</li><li>Master&apos;s Degree or Advanced degree (PharmD, MD, PHD) preferred</li></ul>Experience Qualifications<ul><li>4 or more years scientific background</li><li>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.</li><li>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 Requirements Ability to travel up to 10% of the time. 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. Salary Range: USD$137.840,00 - USD$206.760,00 Download Our Benefits Summary PDF

Associate Director, CDx Regulatory Affairs

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Medical Affairs Diagnostic lead, under leadership of the Executive Director of Research and Strategy, US Oncology Medical Affairs. Develops and implements the USMA diagnostic strategy and tactical plan for all therapeutic areas as part of the US Brand Strategic Plan and leads the execution of the activities in the USMA plan including Launch Readiness and Life Cycle Management. Responsibilities Responsible for the development of the US Medical Affairs strategy and medical objectives for all compounds and leads development, execution of the US Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective. Participates in Global Medical Affairs committees as requested and processes as US Medical Affairs Lead, to gain strategic and planning alignment across the matrix team the core USMA functions. Represents US medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions. Provides medical leadership: oLeads USMA teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts as needed. Partners with RWE and HEOR strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the USMA Plan. oCollaborates with Global Medical Affairs and across USMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data. In partnership with Medical Intelligence and Congress Planning leads, communicates and educates on related competitor data. oProvides medical leadership in scientific engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key thought leaders. Provides medical support for scientific symposium and medical congresses within legal and compliance regulations. oWorks with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education strategies for independent grants, respectively. oProvides input into publication strategy, data gap analysis, and tactical planning as part of the overall USMA plan. Reviews and approves abstracts, manuscripts, and other data disclosure documents. Manage budgets and resources efficiently for USOMA supported activities within the USMA plan, in collaboration with US Oncology Franchise Head Qualifications Education Qualifications Advanced scientific degree (Ph.D., PharmD or MD), equivalent will be considered with relevant experience in a health sciences related field or an equivalent combination of education and experience required Bachelor&apos;s Degree required Experience Qualifications 10 or More Years Pharmaceutical industry experience or commensurate healthcare or research experience required 4 or More Years Post-doctoral and/or relevant industry experience, and expertise in oncology biomarker and/or companion diagnostic development required 4 or More Years (in-house) medical affairs or related experience, US preferred required &bull;Must have oncology experience, specifically in solid tumors &bull;Previous overall responsibility and accountability for multiple indications of one or more compounds and related USOMA plan/budget for related MA activities &bull;Demonstrated ability to lead and influence others internally and externally -Experience leading matrix medical teams and representing medical on cross-functional leadership teams (e.g. US Product Team, US Brand Team, Global Medical Team, etc.) -Relationships with or proven history developing key external experts &bull; Proven ability to manage multiple priorities at one time &bull; Strong knowledge of medical strategy, clinical diagnostic development, and Field Medical activities required &bull;Knowledge of ADC or other biologics, or small molecules &bull;Demonstrated experience working with an alliance partner company preferred Travel Requirements Ability to travel up to 20% of the time. 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: USD$230.175,00 - USD$383.625,00 Download Our Benefits Summary PDF

Senior Director, US Oncology Medical Affairs, Diagnostics

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. 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&apos;s GxP group. Together with regional management teams plans, supports, conducts and reports internal systems and process audits across the organization as appropriate for the area of GxP audits assigned. Responsibilities 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. Ensure trending and signal detection is communicated to stakeholders for risk mitigation. Support the stakeholders in identifying and defining quality improvement initiatives for development activities / programs post internal system audit. Support reporting of quality metrics for audits and inspections and execute against these metrics consistently. Provide inspection management support regarding compliance concerns identified during internal systems audits, remediations implemented and CAPAs pending. Support Risk Mitigation programs to ensure compliance to regulatory guidelines. Ensure up to date audit CAPA information in the eQMS in a timely manner. Collaborate with QMS Team and applicable QA function to ensure no overdue CAPAs. Qualifications Education Qualifications Bachelor&apos;s Degree in a scientific, healthcare or related discipline required Experience Qualifications 4 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance Must have strong 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. Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products strongly preferred Proven experience with Health Authority Inspections, (e.g., FDA, HPFB, MHRA and other European regulatory agencies) International experience is a plus; but at minimum, experience working with diverse cultures and employees is required Demonstrated expertise working within early development through Phase III and Pharmacovigilance studies Travel Requirements Ability to travel up to 10% of the time. 15% domestic and international travel 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: USD$116.400,00 - USD$174.600,00 Download Our Benefits Summary PDF

Manager, Internal Process Audits

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary This position serves as the Global Head of the Statistical Programming Group. The incumbent will be responsible for defining the vision and mission of the programming group; be accountable for the quality, timeline, and strategy of all statistical programming activities and deliverables related to global R&D projects and regulatory submissions; provide leadership and manage the programming group for organization build, talent development, resource planning, and people development; lead the development, improvement, implementation, and maintenance of global programming processes, standards, programing innovation technology, and programming infrastructure; be responsible for the compliance of GxP, SOP/SOI, and other regulations and company policies in programming practice. Oversee and partner with IT to obtain and maintain software used by GBDM (e.g. SAS, R, Python). Support the advancement of new technologies (AI/ML) and new systems (e.g. Clinical Data Repository). Prepare and support inspections related to Statistical Programming activities and deliverables Job Description Responsibilities Statistical Programming Management: <ul><li>Define the vision and mission of the group; manage statistical programming resources to support project needs; be accountable for the quality of the statistical programming deliverables; be responsible for recruiting, retaining, developing, and managing employees; be responsible for talent development including providing guidance for career growth and providing development opportunities for the direct reports. Global Biostatistics & Data Management (BDM) Strategy to Improve Drug Development: Leads the implementation of the BDM vision and strategy, and identifies technology and infrastructure needs and leads the development and improvement of needed technology and infrastructure for the function to improve harmonization and efficiency which leads to cost savings and productivity. Initiate and lead the development or enhancement of global programming processes and standards for statistical programming practice. The leadership of strategic initiative and cross-functional collaboration: Provide leadership for global strategic and process improvement initiatives within Biostatistics & Data Management. Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, QCP, and regulatory affairs, etc. Compliance: Be sponsible for the compliance of GxP, SOP/SOI, and other regulations and company policies in programming practice</li><li>People & Organization Leadership: Lead, develop, and inspire a global statistical programmers and leader; Build a strong leadership bench and talent pipeline through succession planning, capability development, and performance management; Foster a culture of collaboration, accountability, inclusion, and continuous learning. Act as a Statistical Programming Technical expert to the department and the global BDM department.</li><li>Global Biostatistics & Data Management (BDM) Strategy to Improve Drug Development: Leads the implementation of the BDM vision and strategy, and identifies technology and infrastructure needs and leads the development and improvement of needed technology and infrastructure for the function to improve harmonization and efficiency which leads to cost savings and productivity. Initiate and lead the development or enhancement of global programming processes and standards for statistical programming practice.</li><li>The leadership of strategic initiative and cross-functional collaboration: Provide leadership for global strategic and process improvement initiatives within Biostatistics & Data Management. Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, QCP, and regulatory affairs, etc. Represent Statistical Programming in governance forums and senior leadership discussions. Serve as a trusted partner to global stakeholders, including IT, Biostatistics, Data Management and the wider Data Sciences Community at the company.</li></ul>Compliance: <ul><li>Be responsible for the compliance of GxP, SOP/SOI, and other regulations and company policies in programming practice</li></ul>Qualifications Education Qualifications:<ul><li>Bachelor&apos;s Degree Mathematics, Statistics or Computer Science required</li><li>Master&apos;s Degree Mathematics, Statistics or Computer Science preferred</li></ul>Experience Qualifications:<ul><li>12 or More Years with MS or 15 + with BS years minimum experience in pharmaceutical industry. Extensive experience in oncology drug development including NDA and/or BLA submission, extensive hands on experience and knowledge in statistical programming and related processes/standareds, extensive project management skills and experience, people management experience are required.</li><li>6 or More Years Experience in oncology drug development preferred</li><li>5 or More Years of project management and people management experience; sufficient related skills are required required </li><li>Excellent Verbal and Written Communication skills</li><li>Functional and organizational skills and knowledge</li><li>Strategic thinking and business vision</li><li>Interpersonal skills</li><li>Deep technical expertise and experience in R, Python and SAS</li><li>Proven track record of overseeing and knowledge of statistical programming systems</li><li>Experience leading technical/systems initiatives for global BDM</li><li>Experience leading and managing a large global department</li><li>Proven track record partnering with Data Management and Biostatistics globally</li><li>Flexible thinking; able to pivot quickly in a highly dynamic, fast paced environment.</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: USD$266.550,00 - USD$444.250,00 Download Our Benefits Summary PDF

Executive Director, Statistical Programming

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Reporting to the Sr. Director of Trade and Distribution Operations, the Director, Customer & Trade Management leads the development and execution of DSI distribution and channel strategies for its oncology and rare disease product portfolio while achieving contracting, access, and performance objectives with assigned national specialty distributor and specialty pharmacy accounts. The Director of Trade will work collaboratively with diverse members of Supply Chain, Commercial, and Corporate functions to achieve individual, group, and organizational goals. Responsibilities Strategic Account Management: <ul> <li>Lead and advance strategic account relationships with assigned specialty distributor and specialty pharmacy customers.</li> <li>Develop and implement comprehensive account plans to align distribution strategies with brand objectives and patient access goals.</li> <li>Develop and lead negotiation strategies with Trade accounts that secure favorable market aligned terms, conditions, and fees for DSI and its products while ensuring optimal patient, HCP, and pharmacy experience when sourcing DSI medications</li> </ul> Oncology Channel & Distribution Strategy: <ul> <li>Engage directly with key customers, vendors, and internal stakeholders to identify new ways of addressing channel challenges and create win-win-win value for DSI, the account, and the patient and their provider.</li> <li>Develop, implement, and manage channel and account-based product distribution models aligned to Brand strategy, Market Access, and Finance goals. Models and solutions may include: oOrder fulfillment and transportation models oAlternative distribution methods (e.g. direct distribution, drop-ship, other) oLimited or exclusive Specialty Pharmacy arrangements</li> <li>Accountable for channel performance, pull-through, inventory levels, and order patterns to ensure channel integrity and product availability.</li> </ul> Cross-Functional Collaboration: <ul> <li>Drive collaboration with home office teams (e.g. Supply Chain, Finance, Forecasting, Market Access, Brand Marketing, Sales Operations, and Legal) to address a broad range of customer or channel challenges and opportunities and ensure timely analysis, selection, and implementation of strategies and solutions.</li> <li>Partner with Patient Services and Field Reimbursement teams to ensure providers and patients have timely access to DSI products.</li> <li>Provide strategic insights and channel intelligence to support Commercial (e.g. Forecasting and Brand Marketing) planning initiatives in order to achieve channel readiness for new products launches and maintenance of appropriate inventory levels post launch.</li> <li>Partner with Regulatory, Compliance, and Quality teams to ensure all trade activities adhere to legal and industry standards.</li> </ul> Business Analytics & Market Intelligence: <ul> <li>Analyze trade partner data and distribution trends to inform strategic decisions and address barriers to access.</li> <li>Deliver regular performance reviews, including adherence to KPIs , to strategic accounts.</li> <li>Maintain expertise in oncology and rare disease market trends, evolving provider needs, and channel participants (Distributors, Pharmacies, PBMs, IDNs, GPOs, Community Oncology Providers, other).</li> </ul>Qualifications Education Qualifications<ul><li>Bachelor&apos;s Degree required MBA preferred</li></ul>Experience Qualifications<ul><li>10 or More Years overall related experience required</li><li>7 or More Years Demonstrated experience and proven success leading contract negotiations with (and managing) large commercial accounts, developing and implementing innovative distribution models and/or limited distribution networks, and collaborating with diverse stakeholders to resolve complex challenges in Pharmaceutical Managed Care, Trade, Supply Chain, or similar environments. required</li><li>7 or More Years Developing deep understanding of the oncology product lifecycle, including buy-and-bill and pharmacy benefit models, specialty pharmacy, white/brown/clear bagging, and patient access services and models. required </li><li>7 or More Years Building relationships with Trade and Channel participant executives that have enabled and driven successful strategic initiatives with aligned goals and shared value. required Familiarity with REMS programs and cold chain logistics preferred</li><li>Experience managing or collaborating with third-party logistics (3PL) providers preferred </li></ul>Travel Requirements<ul><li>Ability to travel up to 30% of the time. Travel requirements of at least 5-8 days per month and occasional weekend commitments.</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: USD$180.880,00 - USD$271.320,00 Download Our Benefits Summary PDF

Director, Customer & Trade Management

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job 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&apos;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></ul>Additional Qualifications: <ul><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></ul>Compensation and seniority level/title based on experience and qualifications 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: USD$139.440,00 - USD$209.160,00 Download Our Benefits Summary PDF

Oncology Territory Manager, Breast - Nashville East

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary We are currently seeking a Biosample Management Operations Intern from June 2026 - May 2027. This position will be full-time (37.5 hours) in the summer and part-time (20 hours) for the remainder of the internship. Job Description The intern will assist with biorepository operations, vendor oversight, data accuracy verification, and informed consent governance, while collaborating with cross-functional teams including Biosample Management, Precision Medicine, Clinical Study Teams, and Procurement. This role provides hands-on exposure to biorepository processes, compliance requirements, and cross-functional collaboration in clinical development. Responsibilities<ul><li> Assist in managing long-term storage (LTS) at the biorepository and overseeing the coordination of sample movements needed for LTS or post-study analysis </li><li> Provide vendor performance/oversight responsibilities for the Biorepository (e.g. KPI management and oversight, issue escalation, etc.) </li><li> Support the verification of data accuracy at the Biorepository including specimen identifiers and metadata, and ICF-associated permissions prior to utilization. </li><li> Collaborate with Procurement to review contracts and ensure qualification for biorepository vendors responsible for long-term storage. </li><li> Assist the Biorepository Lead and Head of BSM as needed to manage the communication with Precision Medicine and the clinical study teams to address informed consent and IRB/EC questions related to biosamples in long-term storage in the biorepository </li><li> Ensure that samples are tracked, stored, destroyed, and used appropriately in line with the associated Informed Consent Forms and associated SOPs </li></ul>Qualifications<ul><li> Currently pursuing a degree in Life Sciences, Biotechnology, Pharmacy, Pharmaceuticals, or a related field. </li><li> Basic understanding of drug development process, informed consent and biorepository. </li><li> Strong organizational skills with attention to details and ability to prioritize competing timelines. </li><li> Good communication skills and ability to collaborate effectively with internal and external teams. </li><li> Proficiency in Microsoft Office applications. </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: USD$17,23 - USD$58,15 Download Our Benefits Summary PDF

Biosample Management Operations Intern

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Oncology Clinical Educator role provides disease state, REMS, and product safety education and training to key healthcare providers within Oncology clinics, and health care providers (HCPs) in both the hospital and clinic/office setting. The individual will work within a specified region to enhance disease, REMS, and product safety knowledge, coordinate and provide staff training, and enhance proper administration. The Oncology Clinical Educator (OCE) role is a position that is field based and is comprised of nurses working under the general direction of the Regional Director of Clinical Nurse Managers. The OCE is responsible for educating HCPs/clinics with infusion and related education for prescribed DSI products. The OCE serves as the disease state and product safety expert for their assigned territories. The OCE serves as a resource to clinical leaders by identifying disease state, REMS, and product safety educational needs of staff and implements programs to fulfill knowledge gaps. This collaborative approach will serve to provide education and enhanced clinical care. The OCE is bound by the product label for all educational efforts, and in the interaction with non-commercial counterparts. Excellent organizational, creative and analytical problem solving, communication, and presentation and skills are required. This individual must be flexible and adaptable to new and constant changing situations. Responsibilities<ul><li>Provides education to health care professionals about disease states and REMS and product safety information for specified DSI products in the medical community within an assigned geographical area in accordance with DSI general direction and policy, focused on the assigned targeted segments (i.e: Hematology/Oncology, Gastroenterology, Nephrology, Hospital Pharmacy, OB/GYN and Cardiology).</li><li>Develops strong, long-term relationships with clinical personnel</li><li>Ensures appropriate and compliant utilization of product and disease state education as it relates to DSI products.</li><li>Executes disease state educational presentations and on label product safety presentations for in-office/in-hospital educational programs to customers that are guided and designed to address clinical knowledge or product gaps.</li><li>Must be able to educate and use multiple approaches to explain complex and difficult material and use experiences to illustrate ideas and facilitate understanding while maintaining the ability to stimulate customer interest.</li><li>Collaborates to identify and strategizes on how to best educate customers.</li><li>Develops and executes geographical based strategic and tactical plans to meet targeted customer needs.</li><li>Monitor, collect, and communicate to the Director, Clinical Nurse Manager on customer insights regarding their need for information regarding disease state, REMS and safety information with respect to DSI marketed products.</li><li>Collaborate with managed care counterparts or MSLs to provide ongoing clinical updates that are impacted by reimbursement and/or clinical guidelines.</li><li>Identifies and contributes to the development of nursing/HCP specific materials to fulfill customer needs to include, but not limited to, patient educational aids, product reference aids and slide deck content topics.</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&apos;s Degree required</li></ul> Experience Qualifications <ul><li>4 or more years in pharma industry preferred, ideally Hematology/Oncology or 3 or more years of healthcare related experience required</li><li>Experience with infusion nursing experience preferred</li><li>Ability to travel up to 90% within geography and to required meetings.</li></ul> Licenses and Certifications <ul><li>RN - Registered Nurse - State Licensure and/or Compact State Licensure The ideal candidate will be a Registered Nurse with previous relevant clinical as well as pharmaceutical industry experience calling on different levels of the health care providers (HCPs) in both the hospital and clinic/office setting required</li></ul>Additional Qualifications: <ul><li>Ability to travel up to 90% within geography and to required meetings.</li><li>Must have a valid driver&apos;s license with a driving record that meets company requirements</li></ul>Compensation and seniority level/title based on experience and qualifications. 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: USD$140.480,00 - USD$210.720,00 Download Our Benefits Summary PDF

Oncology Clinical Educator - New Jersey

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director, GMA Oncology ADC (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<ul><li>Leads 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.</li><li>Responsible for managing budgets and resources for the assigned GMA plan activities, in collaboration with Sr Director. Leads 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.</li><li>Serve 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.</li><li>Leads external 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 MI&E 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.</li><li>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).</li></ul>Qualifications Education Qualifications PharmD An advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical/ scientific area is required. Experience in oncology therapeutic area is required required or PhD An advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical/ scientific area is required. Experience in oncology therapeutic area is required required or MD An advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical/ scientific area is required. Experience in oncology therapeutic area is required required or DO An advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical/ scientific area is required. Experience in oncology therapeutic area is required required Experience Qualifications 10 or more years of professional pharmaceutical industry experience with medical affairs or other relevant experience 4 or More Years experience in pharma at local, regional and/or Global level. Excellent knowledge of current clinical practice in Oncology / Hematology / Endocrinology or other relevant disease area strongly preferred. Must have knowledge in and understanding of medical activities (including scientific communications, medical information, MSLs, and HEOR), relating to the commercialization of oncology products Travel Requirements Ability to travel up to 20% of the time. 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: USD$206.800,00 - USD$310.200,00 Download Our Benefits Summary PDF

Dir GMA Oncology

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Global Oncology Medical Affairs (GOMA) Director, Program Management & Operational Excellence provides strategic planning and operational management oversight of GOMA projects, activities, and budgets. The Director, Program Management & Operational Excellence is responsible for supporting the Head, Program Management & Operational Excellence, the assigned Global Medical Affairs Team (GMAT) or Functional Lead, and the Franchise or Function Head to deliver GOMA projects and activities successfully and in a timely manner while working in a fast-moving, matrixed organization. The Director, Program Management & Operational Excellence is responsible acting as the "Chief of Staff" for his/her team, leading efforts to achieve overall operational excellence across all activities and projects to accelerate business in a compliant and efficient manner. The Director, Program Management & Operational Excellence further contributes to accelerating and optimizing the business via the following responsibilities / activities: &bull;Leading / contributing to process improvement initiatives &bull;Ensuring streamlined and efficient communication &bull;Escalating issues in a timely manner &bull;Budget management and oversight of contract-to-purchase order (PO) process &bull;Facilitating key meetings (internal GMA, cross-functional, cross-regional, vendor meetings, etc.) &bull;Tracking of activities in terms of timing, anticipated risk, and mitigation of issues/conflict resolutions &bull;Encouraging overall operational excellence across all activities and projects Job Description Responsibilities<ul><li> </li></ul><ul><li> </li></ul>GMAT/Function Support In close collaboration with the Team Lead (GMAT or Function), establish a strategic plan for monitoring the activities per the Business Plan and priorities. Support Team Lead to manage GOMA project/activities, including ensuring that the GMAT/Function team delivers projects/activities successfully and on a timely manner as per annual plan & objectives. Establish milestones and metrics, in collaboration with GMAT/Function team, and develop a detailed project plan in order to track progress and measure impact of the activity. Generates critical path analyses and supports scenario planning for each GMAT/Function, in order to assess if objectives are met, exceeded, or not met. Have a strong understanding of activities, associated budget, and key contributing factors in order to anticipate potential risks and establish plan to mitigate, as appropriate. Lead and facilitate regular internal GOMA & cross-functional/cross-regional team meetings; ensure agendas and team priorities are clear, meetings minutes are distributed, action items are completed. Lead the budget planning and tracking process for GMAT/Function team; work with GMAT/Function Leads to provide consolidated budget/LE updates (across all activities and regions) in a timely manner with appropriate rationale. Support GMAT/Function lead with annual Business Planning process & associated documents, including proactive engagement with internal and external stakeholders to manage plan development. Proactively follow-up on action items and requests of GMAT/Franchise Lead. Support GMAT/Function/Franchise Head in prioritization and planning of resources and develop rationale for annual resource planning. Lead issue resolution meetings. Lead risk identification, prioritization, and mitigation planning processes across the Franchise. Manage the agendas for GMAT/Function meetings, the conduct of the GMAT/Function meetings, and the drafting of GMAT/Function meeting minutes. Ensure full documentation of meeting discussions, decisions and action items. Track & ensure completion of agreed action items. Ensure appropriate archiving of project documentation. Develop a monthly report that provides an overview of progress on all key activities, potential risks and mitigation actions. Generate and maintain strategic integrated GOMA Franchise project plans, project timelines, high quality risk management plans, and communication plans, as needed. Responsibilities Continued Operational Excellence Support Collaborate with Executive Director, Strategy & Operational Excellence to further strengthen operational excellence from a GOMA-wide organization perspective. Disseminate key leadership communications throughout GMAT/Functional teams and lead issue escalation efforts when required. Identify gaps in Global Oncology Medical Affairs processes and functional procedures that (potentially) impact program delivery and escalate appropriately to Executive Director, Strategy & Operational Excellence. Collaborate with Executive Director, Strategy & Operational Excellence and GMAT/Functional Leads for formal presentations/communications to GOMA Head and GOMA Leadership Team. Support Executive Director, Strategy & Operational Excellence with updates to GOMA leadership, as needed. Integrate operational excellence best practices into regular team meetings and communications to enhance overall capabilities. Qualifications Education Qualifications Bachelor&apos;s Degree with relevant professional experience or equivalent required advanced degree preferred Experience Qualifications 7 or More Years experience in project management with at least five years in pharmaceutical industry. required Medical Affairs experience strongly preferred preferred Demonstrated leadership skills, especially in the areas of communication and change management required Meticulous attention to detail in all aspects of work and expert organization skills required Proven ability to drive decision making process, including ability to challenge teams and achieve excellence required Ability to thrive in a fast-paced environment required Self-starter, results-oriented required Strong change management skills and engagement to enable continuous improvement required Strong communication skills and ability to adapt according to different levels of management required Ability to negotiate and align across teams required Demonstrated ability to collaborate effectively with key stakeholders required Strong Microsoft Office skills required required Travel Requirements Must be able to travel domestic and international 10% Additional Information 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: USD$198.160,00 - USD$297.240,00 Download Our Benefits Summary PDF

Director, GOMA Program Management & Operational Excellence

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary<ul><li>This role serves as the primary liaison between DSI IT and business end users, leveraging strong knowledge of commercial and sales operations - as well as other core functions - to understand business needs and support day to day production activities.</li><li>It is responsible for ensuring reliable production support across critical commercial data domains (Sales, Omnichannel, Patient, Marketing, Medical Affairs). This includes managing incidents and inquiries, driving root cause analysis, and restoring services quickly to minimize disruption and protect business outcomes. </li><li>The position requires the ability to approach problems creatively and guide technical teams toward effective resolutions for complex data issues.</li><li>The role works collaboratively with Commercial Data Governance, Compliance, Integration, Infrastructure, and other cross functional partners to support projects and deployments, ensuring solutions align with business requirements, compliance expectations, and technical standards.</li><li>It oversees and enforces change management and release processes so that all system and process updates are properly designed, tested, documented, and deployed in accordance with DSI IT policies - minimizing regressions and maintaining full traceability.</li><li>Additionally, the role manages cloud enterprise platforms - such as Informatica IICS, Veeva Network, SAS, and Power BI - to ensure their availability, correct configuration, operational stability, and ability to scale securely in line with business needs.</li><li>It also manages statements of work and vendor contracts, ensuring adherence to service level agreements, delivery expectations, and overall partner accountability.</li><li>It also demands strong vendor management capabilities and clear, timely communication of issues and resolutions to business stakeholders.</li></ul>Responsibilities<ul><li>Manage and support ongoing operations and change management using vendors and/or internal resources.</li><li>Responsible for SOW and contractual agreements with ongoing support partners.</li><li>Collaborates closely with development / integration teams on new projects and enhancements.</li><li>Participates in weekly / monthly status meetings to review monitoring and reporting on operational health and issues, ensuring continuous improvement via automation and process enhancements.</li><li> Accountable for all aspects of operational process, and other activities essential to the ongoing operations, transparency, documentation, and QA. This includes requirement gathering, design, development, and implementation of analytic, database, integration, and master data management solutions.</li><li>Collaborates with cross-functional teams (project stakeholders, integration, architecture, infrastructure teams, etc.) on development and deployment of analytic dashboards, databases, and applications.</li><li>Manages the review and analysis of business requirements, provides UAT support and guidance / recommendations on scheduling and prioritization for all new processes and workflows.</li><li>Accountable for supporting the 3-year technology roadmap for analytics dashboards, databases and applications, providing expertise based on business needs and evolving trends in the industry.</li><li>Ensures that all system / process changes are properly tested in accordance with DSI IT standards, and that operations guides / runbooks are periodically reviewed and updated. Ensures adequate process monitoring and reporting is in place, and that the support team is proactively and diligently following up on data and technical issues.</li><li>This role works closely across Regional / Global DSI IT teams and is responsible for the ongoing production support of Commercial IT systems and applications.</li><li>The individual in this role owns the support and technical design / development, testing / debugging, deployment, and manages the ongoing production operations of analytic dashboards, databases, applications, and integrations.</li><li>Must have experience leading / overseeing cloud-based enterprise technology platforms that support Integration, Master Data Management, and analytical platforms (i.e., Informatica IICS, Veeva Network, SAS).</li><li>The individual will supervise onshore and offshore teams on the review, prioritization and resolution of data and technical issues.</li><li>Must be able to look at problems in unique ways and guide technical teams on effective solutions for resolving data & technical issues.</li><li>This role acts as a liaison between DSI IT and end-users, requires a strong understanding of commercial / sales operations and other key functions to better understand their needs and support ongoing production operations.</li><li>Must be able to effectively manage vendors and effectively communicate issues and resolutions to business stakeholders.</li></ul>Qualifications Education Qualifications<ul><li>Bachelor&apos;s Degree in Computer Science or a related discipline. required</li></ul>Experience Qualifications<ul><li>1 or More Years of pharmaceutical background required </li><li>4 or More Years of experience with cloud-based Data Integration tools (MS Azure, Informatica IICS or equivalent) required</li><li>4 or More Years of experience with enterprise scheduling / orchestration tools (Tidal Enterprise Scheduler or equivalent) required </li><li>4 or More Years of experience with enterprise Managed File Transfer tool (Cleo Harmony or equivalent) required </li><li>4 or More Years of experience working with MS SQL Server DB, Azure SQL DB and SQL DB Managed Instance required </li><li>1 or More Years Pharmaceutical Customer Master experience supporting Commercial Operations and Compliance needs preferred</li><li>1 or More Years Has a comprehensive understanding of data warehousing, ETL / ELT, dimensional modeling, normalization, indexing and partitioning required</li><li>1 or More Years Managing third-party vendors that support databases, advance analytical systems, data warehousing and manage data management systems. preferred </li><li>1 or More Years Ability to understand and analyze the complex system and provide quick solutions to resolve issues and meet new requirements required</li><li>1 or More Years Must be a self-starter with demonstrated ability to learn new technologies to succeed in the role. preferred </li></ul>Travel Requirements<ul><li>Ability to travel up to 10% of the time. Business meetings or conferences as needed</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: USD$124.960,00 - USD$187.440,00 Download Our Benefits Summary PDF

Manager, Data Management and Operations

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or siRNA drug projects consistent with the company goals. Participate on G-RACMC teams and support or lead on Component teams and/or serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams leading to sound scientific development programs and successful registration for new compounds. Performs collaborative authoring with other RACMC regional team members and subject matter experts for Health Authority (HA) submission, HA meetings, and responses to HA queries. Support company goals to building filing strategies that lead to efficient submission timeline and approvals in assigned region. Digital Transformation Responsibilities: The Associate Director, Digital Transformation (within Regulatory CMC), will serve as a strategic leader and change agent driving the organization&apos;s transition toward structured CMC data and next-generation digital capabilities. This role is critical to enabling the future of regulatory submissions, modernizing end-to-end CMC data management, and positioning the company for global competitiveness in an increasingly data-driven biopharmaceutical landscape. Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred. Responsibilities<ul><li>Organize and manage the preparation (content and format) of all types of submissions to Health Authorities.</li><li>Coordinates activities required for timely and accurate reporting of information to existing submissions.</li><li>Supervise the identification and compilation of required documentation for submission.</li><li>Prioritizes workload. Evaluate content and adequacy of submissions and identify deficiencies against regulatory guidance's or internal data bases.</li><li>Facilitate and support liaison activities with functional groups within Daiichi Sankyo, Inc. related to assigned products/project areas such as the clinical supplies organization, Reg Operations, Medical Affairs and labelling.</li><li>Participates in meetings with Health Authorities.</li><li>Prepares internal functional teams for these interactions to build strong relationships with FDA and secure successful meeting outcomes.</li><li>Coordinates preparation, authors, and finalizes meeting materials to include meeting requests, briefing books and meeting minutes.</li><li>Keep current with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical seminars, global forums or trip reports.</li><li>Participates on external industry consortiums (DS Consortium and Biophorum) to understand industry standards and contribute to policies and or standards. Identifies areas for process /procedure improvements and works on improvement implementation.</li><li>Provides training on evolving regulations. This could involve Global RACMC teams or cross-functional initiatives within the company.</li><li>Lead the transition to structured CMC data, including data standards, metadata models, and systems that support machine-readable regulatory submissions.</li><li>Drive digital modernization by implementing tools for structured content authoring, automated data transfer, and data-driven dossier creation.</li><li>Enable automation, AI, and analytics to reduce manual data handling, improve data integrity, and enhance decision-making across CMC functions.</li><li>Partner cross-functionally with CMC, Quality, Manufacturing, Technical Operations, Regulatory, and IT to ensure alignment and readiness for structured data capabilities.</li><li>Manage organizational change, including capability building, training, and communication to support adoption of new digital processes.</li><li>Monitor global regulatory and industry trends and lead internal initiatives that position the company for future structured submission expectations and digital regulatory innovations.</li></ul>Qualifications Education Qualifications<ul><li>Bachelor&apos;s Degree Life Science Degree required Master&apos;s Degree preferred PharmD preferred</li></ul>Experience Qualifications<ul><li>7 or More Years in the pharmaceutical industry with significant experience in scientific/regulatory fields required</li><li> Experience in Digital Transformation within Regulatory CMC required</li><li> Experience in international Regulatory Affairs- CMC preferred</li><li>Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.</li></ul>Travel Requirements<ul><li>Ability to travel up to 10% of the time.</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: USD$159.440,00 - USD$239.160,00 Download Our Benefits Summary PDF

Clinical Study Manager, Global Clinical Operations - 30014765

Clinical Study Manager, Global Clinical Operations - 30014765

Clinical Study Manager, Global Clinical Operations - 30014765

Clinical Study Manager, Global Clinical Operations - 30014765

Oncology Territory Manager, Hematology - Pittsburgh

Associate Director, QMS Training & Document Management (Global R&D & PV QA)

Senior Director, USMA Oncology

Manager, PV Quality Management

Associate Director, CDx Regulatory Affairs

Senior Director, US Oncology Medical Affairs, Diagnostics

Manager, Internal Process Audits

Executive Director, Statistical Programming

Director, Customer & Trade Management

Oncology Territory Manager, Breast - Nashville East

Biosample Management Operations Intern

Oncology Clinical Educator - New Jersey

Dir GMA Oncology

Director, GOMA Program Management & Operational Excellence

Manager, Data Management and Operations

Associate Director, Regulatory Affairs CMC and Digital Transformation

Blog

JOB SEEKERS

EMPLOYERS

COMMUNITY PARTNERS

ABOUT

RESOURCES