
Medical Director, US Medical Affairs, Women's Cancer
- Nutley, NJ
- Permanent
- Full-time
- Develop medical strategy for major products and/or indications and provide critical medical input into the lifecycle management strategies in responsible therapeutic areas.
- Plan and implement Phase IV clinical development programs for assigned products.
- Create IIS strategies and review proposals in conjunction with company policies.
- Participate in review of CME grants.
- Serve as a medical leader and subject matter expert for relevant external (HCPs, strategic alliances etc.) and internal stakeholders.
- Serve as a medical expert to provide direction for assigned products on key internal business processes including active participation in relevant medical review committees.
- Work with key internal stakeholders to support development and communication of medical plans for the therapeutic area and track progress for reporting.
- Seek all relevant approvals of medical and scientific content for assigned therapeutic areas.
- Incorporate insights from scientific trends and treatment landscape by participating in external events and activities.
- Liaise with external stakeholders to solicit feedback and strengthen Eisai’s medical reputation in the disease state community.
- Direct and manage financial planning/forecasting and budget management, vendor management, timeline development & tracking, and assess resource needs for respective program(s) within scope of work.
- Manage talent within own area in terms of goal setting, performance management, development, and engagement.
- 10+ years of relevant experience in the pharm/biotech industry
- Advanced degree in sciences (PharmD, PhD, or MD) with substantial experience in the pharma/biotech industry.
- Deep subject matter expertise in relevant area along with a broad overall experience.
- Preferred experience in the Oncology Therapeutic area including in an in-house Medical Affairs role in a strategic decision-making capacity.
- Practical knowledge of FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.
- Substantial experience across areas of Medical Affairs' functions or phase II/III/IV clinical trials and diseases in the therapeutic area is preferred.
- Past leadership experience with management responsibilities (budgets, resources, vendors etc.) for cross-functional teams at a country/ large-region level.
- Business need driven role based on proven performance in earlier role.