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Senior Director, Global Oncology Medical Affairs, Evidence Generation - Basking Ridge, United States - Daiichi Sankyo
Description
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 Senior Director, Global Oncology Medical Affairs, Evidence Generation role is responsible for co-leading a cross-functional Evidence Generation Team and developing an Integrated Evidence Plan (IEP) for the assigned compound with a possibility of working in collaboration with a strategic alliance partner.
Responsibilities
- Co-lead a cross-functional Evidence Generation Team (EGT) for the assigned compound in partnership with Global Health Economics Outcomes Research partner. Ensure alignment of the Integrated Evidence Plans (IEP) with the Alliance Partner.
- As a member of Global Medical Affairs Team (GMAT, or Joint Medical Affairs Team for Alliance compounds) and as a subject matter expert (SME), in alignment with the GMAT Lead, develop an Integrated Evidence Plan (IEP), which includes an evidence gap assessment, gap prioritization and strategic delivery plan. The plan integrates the global/ regional/ country strategies across all relevant functions and aligns with the Disease Area Strategy. Ensure alignment of the gap assessment, gap prioritization and IEP with the Alliance Partner.
- Communicate progress to relevant internal stakeholders using trackers and tools generated by Global Oncology Medical Affairs Study Operations partners and propose mitigation plans for delayed activities. Ensure that appropriate internal and external communication is current and clear. Ensure communication of the progress includes the stakeholders at the Alliance Partner.
- Drive the development of Areas of Interest (AOI) for Externally Sponsored Research (ESR). Align AOIs with GMAT and GPT. Ensure alignment of the AOI with the Alliance Partner.
- Share and discuss the evidence gaps and Integrated Evidence Plans within the team of EG Leads responsible for other compounds within the same Disease Area and with the Disease Area Strategy Leads
- Serve as a delegate on relevant concept and protocol review committees (within company as well as in the Alliance) for company sponsored and externally sponsored research
- Monitor the consistency of IEP process across all asset teams in collaboration with other EG Sr Directors, propose the process modifications and lead the implementation across the asset teams.
- Provide functional excellence expert support and coaching to junior EG team members.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- PharmD, PhD or MD in scientific discipline required
Qualifications
- 10 or More Years overall related experience and/or commensurate education/experience required
- 7 or More Years working in a pharmaceutical company in an Evidence Generation -related role required
- Experience developing global or regional medical strategy preferably in lung and/or breast cancer required
- Oncology launch preparation and delivery in Global, Regional or Country Medical Affairs required
- Experience planning and conducting Medical Affairs interventional and non-interventional studies, including Ph 3b/4, EAP, externally sponsored research, external clinical collaborations, and observational studies required
- Prior experience working in an alliance with another pharma company strongly preferred
Travel
Ability to travel up to 20%
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
