The EU Country Medical Director will be accountable for medical affairs oversight and governance for the assigned Region and will play a key role in the design and implementation of a Regional Medical Affairs plan to provide the scientific support for marketed products and products in development. The incumbent will manage the Oncology group in the Country; supply medical insight into promotional material along with learning materials for internal and external use; actively contribute medical and scientific input to relevant internal brands, and manage market teams regarding product strategy; and actively contribute to medical input for local investigator initiated research and global medical and clinical activities with global therapeutic area physicians, including global brand strategy, global clinical trials, brand safety profile discussions, and the global brand payer dossier.
The position is responsible for scientific leadership in the assigned Region, and for ensuring alignment with Global Medical Affairs. In addition, local scientific roles will report into the Country Medical Director on either a direct or a matrix/operational basis. The incumbent will also ensure that Medical Affairs strategies are aligned with Oncology medical strategy, global brand planning, and ongoing late stage development lifecycle management plans.
• Lead the Country/Region’s Medical Affairs organization with responsibility for the generation of medical strategy development.
• Serve as the Country Scientific Leader with local managerial and leadership support responsibilities for scientific staff such as safety, regulatory, technical operations (CMC) and local clinical development staff.
• Liaise and coordinate issues and professional development of the scientific staff with the global primary managers and ensure that local needs are addressed.
• In addition to generation of scientific data to support medical claims, provide input for the generation of health economic outcome data to support reimbursement.
• Have responsibility for the provision of input to Research & Development to assist with the lifecycle management of the products for the Region, including developing and disseminating appropriate scientific data and ensuring that all Medical Affairs activities are conducted with utmost integrity and compliance.
• Oversee the alignment of medical strategies and communication plans, support resources and budget to ensure the medical and commercial needs / opportunities of the Region’s Oncology business are met.
• Work with medical staff to support integration and communication to regulatory and development teams with strategic medical input where appropriate; ensure regional medical affairs activities are scientifically sound, within relevant guidelines, and of a high standard.
• Provide input and guidance to medical information and strategy team within the Region to support optimal medical communications and development strategies for the Region.
• Recommend Regional studies, medical affairs activities and potential investments to Global Medical Affairs leadership.
• Ensure compliance with Regional directives for, amongst others, the release of promotional material, medical representative training materials, and medical information.
• Together with other members of the Global Medical Affairs team, establish and maintain strong relationships with key opinion leaders on behalf of Clovis Oncology in all relevant areas.
• Lead and participate in Regional Medical and Scientific forums (i.e., advisory boards and educational) that involve scientific leaders.