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

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CDx Associate Director, Global Regulatory Affairs

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data reconciliation, external data acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards and specifications across clinical studies. This position involves managing direct reports and/or leading multidisciplinary teams, as well as overseeing functional service providers to achieve business objectives. It requires extensive knowledge of clinical data programming, external data handling, techniques, standards, methodologies, and skills in working with internal and external systems, CROs, and vendors. Excellent verbal/written communication, analytical, organizational, and interpersonal skills are essential for effective collaboration with individuals at different levels and from diverse disciplines and cultures. Line management experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations, Pharmacovigilance, handling and processing of raw data and external data, CDASH/SDTM, industry best practices, and relevant regulatory requirements is essential. This position demands significant skills in working in fast-paced environment, continuous improvement, project management, change management, and risk management. Responsibilities: Leadership, Direction, and Strategy: <ul><li>Is accountable for the management and oversight of all DM programming, reporting, and external data acquisition and validation deliverables for all studies consistent with IDRP, study data listings, exception data listings, sample reconciliation, external data acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution of external data -- acceptance, storage, and delivery activities to ensure complete, high-quality data is available for use by clinical study teams in a timely manner. Provides oversight for external data validation and quality control process for verification of the data structures in line with data transfer agreements. Manage and oversee the DM programming staff and Functional Service Provider subject matter experts at the functional level to support project portfolio milestones, and/or initiatives to achieve/exceed departmental quality/time/cost objectives.</li><li>Leads development and implementation of DM reporting strategy and solutions at the program level to achieve/exceed quality, time, and cost objectives embracing agile programming methodologies, novel approaches, and industry best practices. Drives execution of the DM programming, reporting, and data visualization activities across all studies to ensure on-time delivery of accurate and high-quality programming deliverables.</li><li>Champions and facilitates change management through providing rationales, describing improved outcomes and increased efficiencies to achieve programming operational excellence. Provides strategic input, develops tactical approaches, and proposals to advance DM Data Validation and Reporting initiatives. Leads or participates in departmental and/or multidisciplinary teams working on continuous process improvements and other initiatives. Proactively identifies and manages risks to data quality, data integrity, programming and reporting deliverables, and timelines. Collaborates with various Governance/Steering Committees, Functional Line Management, and multidisciplinary teams to develop, implement, and promote efficient programming methodologies and techniques, optimizing programs and outputs for quality, efficiency, and positively influencing daily operations.</li><li>Functions as the DM Operations Data Validation and Reporting escalation point for all programming, reporting and external data validation deliverables across all studies; proactively develops solutions within and across functions and resolves complex issues and conflicts in a timely manner. Identifies Data Validation and Reporting staffing needs, prepares annual resource projections, monitors staff utilization, participates in assessment and hiring of candidates. Performs line management duties (provides feedback, conducts formal reviews, confirms training completion, and drives career development) for direct reports, and mentors DM Operations Data Validation and Reporting staff. Directs programming representation in audits and regulatory inspections to provide relevant programming and reporting information as needed. Provides input for DM questions in health authority information requests. Builds and maintains positive business relationships with other line functions, vendors, and partners; is an ambassador and advocate for the data operations programming function with key internal and external stakeholders. Promotes Daiichi Sankyo values and quality workplace culture, collaboration in cross-functional and multicultural settings. Represents Daiichi Sankyo DM at professional conferences/meetings.</li></ul>Project Management: <ul><li>Is accountable for the completion of DM programming, reporting, external data acquisition, processing, and validation activities for drug programs under the outsourcing and in-house operating models. Is accountable for the quality, integrity, and timely delivery of all external data in line with the established data transfer agreements. Is accountable for oversight for DM Data Validation and Reporting resources, CROs, and vendors to ensure compliance with the programming standards and practices, SOPs, external/internal data standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines. Accountable for inspection readiness of DM programming documentation filed/archived according to applicable Daiichi Sankyo and regulatory requirements.</li><li>Communicates with Data Operations leadership, asset leads, DM staff, and cross-functional team leads regarding goals, expectations, timelines, overall status, risks, data trends, and issues. Proactively responds to the needs of the asset leads, DM staff, and cross-functional teams and influences appropriately to ensure successful delivery of the programming deliverables aligned to business priorities. Leads prioritization and planning with the teams to ensure outcomes meet expectations.</li></ul>Functional Expertise: <ul><li>Assesses vendor Scope of Work for Data Validation and Reporting needs; engages in vendor meetings; reviews and evaluates RFPs; contributes to the proposals for contracted programming external data services; manages vendor relationships by coordinating at the governance level. Instills incorporation of industry DM programming best practices, reporting technologies, and discipline to achieve operational excellence. Accountable for adherence to DM programming standards, methodologies, data standards, and reporting technologies ensuring quality delivery of DM programming and reporting services. Provides guidance and expertise on programming of complex data listings and reports, usage of tools and technologies, data extraction mechanisms, data visualizations, and automation to advance the maturation of programming, reporting, and external data validation capabilities. Expertise in code optimization, frameworks/libraries, testing strategies, ETL/ELT capabilities, optimizing data flows, data normalization, reporting processes; data and programming standards; emerging data capabilities and methods. Implements quality-by-design approaches to confirm the quality, integrity, and fit-for-use of the external data based on appropriate and/or established data-cut-off as a pre-requisite for database lock.</li></ul>Operational Efficiency / Continuous Improvement: <ul><li>Provides leadership for operational efficiencies and productivity gains through improved programming standards, code optimization and reuse, data capabilities and methods, and automation. Challenges the status quo, encourages innovation, takes suitable risks to drive improved outcomes through agile programming methodologies, novel approaches, and technology aimed at improving quality and efficiencies. Evaluates repetitive tasks, programming errors, testing strategies, and expedites the delivery of high-quality outputs through automation. Establishes key performance indicators and continuously monitors them to detect trends and pinpoint areas for enhancements. Leads or participates in cross-functional process improvement initiatives. Maintains awareness of and disseminates information about emerging trends, best practices, data standards, clinical programming methods, techniques, and technology recommendations to enhance business capabilities, improve compliance and achieve operational efficiencies. Develops and maintains networks with thought leaders in DM and related areas.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education: <ul><li>Bachelor's degree in life sciences or related field required</li><li>Master's degree in life sciences or related field preferred</li></ul>Experience: <ul><li>11 or more years of experience with Bachelors (or 9 with Master's degree). Experience includes database and data validation programming and/or related work experience in a medical device, biotech, or pharmaceutical company, or similar environment (e.g., CRO); knowledge of industry standard clinical technologies, data standards, raw data handling and processing, external data acquisition, validation, reconciliation, and data visualizations/analytics experience required</li><li>5 + years managing people required</li><li>5+ managing initiatives required</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $185,840.00 - $278,760.00 Download Our Benefits Summary PDF

Director, Data Management Reporting

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

Global Head, Statistics Oncology HEOR/HTA

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Responsibilities: - By leading internal programming contractor or by self, perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity - Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality, proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and verify completeness of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF) - Maintain institutional knowledge across oncology compounds and support building up oncology programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities include: contribute to CRF and SDTM standard development, support develop, implement, and maintain Analysis Data Model (ADaM) dataset and TLF standard, develop sample programs to generate standard ADaM dataset and TLFs, support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis - Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include: create TLFs to support submission QAs in a quick turnaround, support ad-hoc and exploratory analysis requested by clinical team, provide programming supports in agency response or potential Advisory Committee Meeting - Develop and maintain programming macros to effectively support internal data review and monitoring. Responsibilities include: work with Biostatistics member to define the requirements of efficacy data review, develop macros and support the internal data review and monitoring on an ongoing basis Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Master's Degree Biostatistics or similar degree required - PhD Biostatistics or similar degree preferred Experience Qualifications - 6+ Years of proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a masters degree required - 3+ Years of proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a PhD preferred - Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming. preferred - Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred - Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials. preferred - Having knowledge of all phases of drug development, including early and late phase clinical development and submission preferred - Having solid background of applied statistics preferred - Solid knowledge of new advanced statistical methods using SAS preferred - Knowledge in database structures and set-up preferred - The candidate should have successfully provided programming expertise at the Project level for at least two global development projects that have been submitted to regulatory agencies preferred Travel: Ability to travel up to 10% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Statistical Programming

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

Meetings & Project Support Associate, Global Project Management

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

Oncology Territory Manager, Breast - Winston Salem, NC

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

Oncology Territory Manager, Lung - Manhattan N

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

Regulatory Implementation Services Lead

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary<ul><li>This role is key leadership position within Global QMS and Global Quality Assurance. Overall accountability is develop strategic framework work for GxP document management and GxP training across DS group including business units, functional units and corporate functions.</li><li>Lead Training function team and Document and record management function team to enhance training and document and record management across Global cross functional GxP areas in the DS group</li><li>Responsible for the development of cross-functional training strategies Strategic roadmap including , infrastructure, programs, and document/record management principles</li><li>Responsible for the development of document and record management principles for Global GxP activities</li></ul>Responsibilities Training Function <ul><li>Team Lead development of strategies for the needs assessment, design, planning, delivery, and evaluation of training across the organization. Work with functional GQA ( GMP RDPV) on implementation of strategy including development of role based curriculum approach and resources for training administration.</li><li>Lead establishment and enhancement of common Global infrastructure for training, including systems, tools, materials, facilities, and trainers</li><li>Working with eCompliance as Global Business owner for ALTOS global system following governance model</li><li>Lead training related risk analyses and escalate them to senior leadership in GQA</li><li>Responsible for development, oversight, and maintenance of GQA training programs to ensure cross-functional transparency and consistency</li><li>Ensure necessary support is provided to QA functions to develop training curriculums and conduct them in line with the overarching training strategies</li><li></li></ul>Document and record management function<ul><li>Lead document hierarchy definition, and ensure GxP documents across the organization follow the hierarchy</li><li>Lead establishment of principles for document and record management processes including authoring, review, approval, storage, and revision</li><li>Responsible for development, implementation, oversight and maintenance of document and record management principles</li><li>Ensure tools and materials related to Global QMS documents are properly overseen and managed. Working with eCompliance as Global Business owner for Veeva Vault/QDocs global system following governance model</li><li>Ensure administrative support is provided to QA functions including assigning document IDs and quality check to ensure documents and records are properly managed</li><li>Ensure support is provided to QA functions to manage GxP documents and records in a way aligned with the overarching document and record management principles</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>Must have a Bachelor's Degree Bachelor's degree (Scientific discipline). A master's degree or advanced degree is preferred.</li></ul>Experience Qualifications<ul><li>Must have 10 or more years of progressive experience in GxP related functions including at least 5 plus years of experience within progressive GxP-Quality Assurance or equivalent</li><li>Must have a minimum of 5 years of expertise within Global Document and Record Management and Training functions</li><li>Must have proven people leadership experience.</li><li>Must have demonstrated project management skills and experience working on global projects and teams</li><li>Must have proven ability to work cross-functionally within a matrixed global teams environment</li><li>Must have a broad understanding of quality management system, GxP regulations and industry trend/practice</li><li>Must have strong interpersonal skills to build collaborative relationships</li><li>Must have excellent written and oral communication skills. Strong command of English</li></ul>Preferred Skills <ul><li>Extensive knowledge and experience in developing and managing training programs and infrastructure</li><li>Experience with Veeva Quality Docs System & ComplianceWire training platforms</li></ul>Travel Ability<ul><li>Must have the ability to travel up to 10% both domestic and internationally.</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: $206,025.00 - $343,375.00 Download Our Benefits Summary PDF

SR. Director, Head of Document Mangement & Training GQA

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

Senior Analyst - Veeva CRM

Join a Legacy of Innovation - 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Sr. Director, Data Quality and Integrity (Global R&D & PV QA) ensures high standards of data quality and compliance within Global R&D & PV QA. This role leads cross-functional teams to deliver innovative data solutions, integrates AI technologies, and drives process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance, and engages stakeholders to foster a culture of compliance and accountability in data management practices. The position also involves risk-based validation of IT services and determining audit targets for GxP systems. Responsibilities Leadership and Strategic Direction<ul><li>The Sr. Director, Data Quality and Integrity is essential in maintaining Daiichi Sankyo's high standards for data quality and integrity.</li><li>This position reports to the Head, Global QMS (RD PV QA) and is a member of the leadership team.</li><li>Lead an enterprise cross-functional QA team to deliver state-of-the-art data-driven solutions.</li><li>Design a fit-for-purpose organization for operational and technical QA oversight.</li><li>Drive innovative process improvements across RD, PV, and Medical Affairs by leveraging emerging technologies and industry best practices.</li><li>Ability to facilitate through proactive and strong leadership; business process excellence to facilitate process simplification and improvement initiatives.</li><li>Ability to implement vision and strategy within the responsible line functions. Set the strategic direction to define best approach for clinical development systems, PV systems and MA systems including data management, statistical programming, digital technologies, and clinical operations.</li><li>Design and implement a fit-for-purpose organization responsible for operational and technical oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems.</li><li>Lead the development of the global Data Integrity strategy and promote a quality culture throughout the Global RD PV QA organization.</li><li>Champion and disseminate educational materials and initiatives related to quality concepts across global teams.Lead and inspire cross-functional QA teams to implement effective data quality and integrity initiatives.</li><li>Develop and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as those from Quality Events, Audits Findings and Regulatory Inspection (FDA/EMS/ PMDA etc.)Guide/advice RD, PV, MA business functions on the creation of Corrective and Preventive Actions (CAPA) to ensure compliance and improve data quality.</li></ul>Compliance and Quality Oversight<ul><li>Play a key role in ensuring compliance with regulatory requirements while driving innovative quality solutions.</li><li>Collaborate with Global QMS eCompliance team to drive harmonization of systems specific to RD, PV, and Medical Affairs.</li><li>Oversee and ensure the deliverables of key stakeholders, including RD, PV, and MA, focusing on establishing and executing QA plans and strategies that promote data integrity and effective data governance.</li><li>Actively engage with stakeholders to cultivate a culture of compliance and accountability in data management practices.</li><li>Ensure that the organization complies fully with all regulations relevant to computerized systems design, build, and implementation.</li><li>Ensure that the organization complies with all applicable regulations related to computerized systems, including GxP (GCP/GVL/GCLP/GLP).Collaborate with the Audits Compliance (RDPVMA) team to determine relevant audit targets for GxP computerized systems and ensure consistent compliance practices.</li><li>Collaborate effectively with IT to align system development with business and regulatory expectations. Review systems for affiliate companies to assess data integrity and implement corrective actions. Manage relationships with stakeholders (RD, PV and MA) to drive timelines and report on key deliverables related to quality and compliance.</li></ul>Proactive Quality and Risk Management<ul><li>Lead initiatives that integrate AI technologies to enhance data quality and integrity, including developing predictive algorithms for fraud detection.</li><li>Utilize advanced data analytics techniques to monitor data integrity and identify anomalies indicating potential compliance issues.</li><li>Determine effective and efficient risk-based approaches for validation and qualification of IT services.</li><li>In collaboration with Audits Compliance team, determine relevant audit targets for GxP computerized systems for consistency.</li><li>A seasoned quality leader with the ability to assess technology and computerized systems fit for business purposes and compliant with regulatory requirements.</li><li>Deploy data analytics and ensure that data investigations stemming from systems used for data collection are properly investigated and that technology-related audits are conducted.</li><li>Oversee and guide quality assurance processes related to project specifications, ensuring standard procedures are followed.</li><li>Deploy a risk-based approach for the validation and qualification of IT services, ensuring that all relevant quality standards are met.</li><li>Proactively assess and address operational gaps related to quality systems and compliance, fostering a culture of sustainable compliance.</li><li>Ensure proper documentation and adherence to quality standards in ongoing projects and processes.</li><li>Coordinate with the Quality Management System (RDPVMA) teams to support the audit functions, including technology-related audits, risk assessments, and inspections, ensuring alignment with overall quality standards and compliance requirements.</li></ul>Data Analytics and Continuous Improvement:<ul><li>Utilize data analytics to monitor and investigate data integrity across systems used for data collection.</li><li>Champion a culture of continuous improvement in data integrity practices, leveraging feedback from audits, industry trends, and technological advancements to enhance data management strategies.</li></ul>Stakeholder Engagement and Collaboration:<ul><li>Facilitate effective communication and collaboration with internal stakeholders, including IT and Compliance Risk Management as well as Global QMS, QMS (GMP-QA).Ensure leadership oversight of GxP (GCP/GVP/GLP/GCLP) projects and CSV requirements, driving timelines and accountability for key quality deliverables.</li><li>Collaborate with internal stakeholders to identify training needs and support initiatives that enhance the skills and capabilities of team members in quality management.</li><li>Foster a culture of continuous learning and professional development within the RD PV QA by sharing best practices and encouraging participation in relevant training programs.</li><li>Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance.</li><li>Keep abreast of evolving regulations and industry standards concerning data integrity, representing the company in industry forums or regulatory discussions when relevant.</li><li>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.</li><li>Education Qualifications (from an accredited college or university)</li></ul>Qualifications Education <ul><li>Must have a Bachelor's Degree Bachelor's degree in Life Sciences, Pharmacy or Medicines required. An advanced degree such as a Master's degree preferred, PhD or other advanced degree in Life Sciences, Pharmacy or or Medicines preferred.</li></ul>Basic Qualifications<ul><li>Must have 10 or more years of professional experience in Quality, IT compliance and clinical development in the pharmaceutical industry with involvement in regulated clinical trial and / or technical QA activities (i.e., eClincial, Data management).</li><li>Must have at least 7 or more years of professional experience in advance technologies such as AI, data analytics and strong data analysis.</li><li>Must have proven knowledge of global expectations of Health Authorities</li><li>Demonstrated extensive knowledge of ICH- GCP including FDA/EU / PMDA regulations, pharmacovigilance, new drug regulations, other key HA guidance's, and current industry practice.</li><li>Demonstrated experience of successfully leading an organization or projects of high impact</li><li>Demonstrated leadership and accomplishments in a global/matrix environment</li><li>Must have excellent verbal and written communication skills</li><li>Strong interpersonal and prioritization skills with demonstrated ability to build collaborative relationships</li><li>Excellent problem solving and decision-making skills. Skilled at conflict resolution / negotiation.</li><li>Strong project management skills</li><li>Considerable organization awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams across different regions of the world Considerable organization awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross- functionally and in global teams.</li><li>Strong Industry Network in clinical development. Knowledge and understanding of cultural differences and diversity issues.</li><li>Fluency in English (oral and written), other languages a plus but not necessary.</li></ul>Travel Ability Must have ability to travel up to 20% both international and domestic. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Senior Director, Data Quality and Integrity, Global R&D & PV QA

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

Senior Director, Head of RBQM

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

Senior Director, Oncology R&D Functional Excellence

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