Director, Global Oncology Medical Affairs, Evidence Generation

Location: Basking Ridge

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Summary The Director, Global 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. Responsibilities Co-lead a cross-functional Evidence Generation Team (EGT) for the assigned compound in partnership with Global Health Economics & Outcomes Research 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. 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. Drive the development of Areas of Interest (AOI) for Externally Sponsored Research (ESR).

Align AOIs with GMAT and GPT. 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.

Qualifications Education Qualifications PharmD, PhD or MD required in scientific discipline required Experience Qualifications 10 or more years overall related experience and/or commensurate education/experience required 4 or more years working in a pharmaceutical company in 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 Travel Requirements Ability to travel up to 20% of the time.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: USD$ - USD$ Download Our Benefits Summary PDF