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 15,000 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.
The Director, Global Medical Affairs (GMA) Oncology, Biomarkers & Companion Diagnostics (CDx) is a dedicated GMA expert to partner with the GMA Team Lead and cross-functional stakeholders in development of and input into GMA, clinical development, commercial, and market access strategic imperatives related to biomarker and CDx within the Oncology Therapeutic Area. The role also drives development and execution of GMA tactics related to Biomarker and CDx to support the assigned compound portfolio and business strategies.
- Evidence generation
- Serve as a strategic partner to GMAT Lead/TA Directors in development of and driving execution of the GMA Plan to support the overall portfolio and business strategies related to evidence generation, medical information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement
- Serve as biomarker and CDx lead for select company-sponsored GMA evidence generating studies/projects and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders
- Serve as a member of the GMA Evidence Generation Team
- Support review of investigator-initiated studies (IIS) and serve as deputy compound lead in Global IIS Review Committee meetings
- Medical strategic planning and implementation
- Drive the development of GMA strategies and tactics for assigned compound indications related to Biomarkers and CDx
- Active contributor and member of the Global Medical Affairs Team (GMAT) to ensure alignment of global medical and cross functional strategies
- Gains strategic and planning alignment across regions and functions and supports review of local country/regional medical affairs activities related to biomarker and CDx when applicable
- Provide input and support for related strategies and initiatives of the R&D clinical development and Biomarker/CDx, Commercial and Market Access plans
- Drive Biomarker and CDx medical readiness activities for market launches and life cycle management
- Scientific education, communication, and engagement
- Establish and maintain internal and external relationships, and represent GMA in stakeholder engagements to facilitate medical input and activities
- Serve as an expert in biomarkers and companion diagnostics, including information from scientific journals and congresses, to alert GMAT and other relevant stakeholders of critical new information that may affect strategies/plans
- Provide scientific & medical education to medical affairs staff, and other team members related to, biomarker, diagnostic and disease-specific information
- Engage with key external experts, including oncologists, scientists, pathologists to identify relevant gaps and areas to be addressed in support of medical and market launch initiatives, including questions and topics to be addressed by Field Medical Affairs, Scientific Exchange, Congress Medical Information, and other relevant aspects, etc.
- Develop and implement a responsible budget stewardship
- Develop and effectively manage annual operating plan and budget for the biomarker and CDx team
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 with relevant training required
- 7 or More Years in pharma required
- 1 or More Years minimum of 3 years of medical affairs experience required, global preferred
- Must have oncology experience, specifically in solid tumors required
- Previous overall responsibility and accountability for multiple indications of one or more compounds and related GMA plan/budget for related MA activities
- Demonstrated ability to lead and influence others internally and externally
o Experience leading matrix medical teams (e.g. GMAT) and representing medical on cross-functional leadership teams (e.g. Global Product Team, Global Brand Team, etc.)
o Relationships with key opinion leaders
- Immunohistochemistry (IHC) and/or next generation sequencing (NGS)
Ability to travel up to 30% domestic and international travel
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.