Senior Director Medical Affairs CNS
This rapidly growing CNS bio-tech is looking to hire a Senior Medical Affairs Director to focus on pivotal Phase IV clinical trials and provide planning and strategic expertise to their medical affairs activities. This role will have excellent visibility to the CMO and will be vital to the continued growth of this biotech as a provider of medicine to the Neurology & CNS field.
Primary Responsibilities:
- Plan and execute the Medical Affairs Phase IV study program working closely with cross functional partners, including regulatory, commercial, clinical development, and clinical operations
- Lead the development of updates and presentations to senior leadership on the phase 4 program
- Provide strong technical and medical expertise to execute on defined strategies
- Working closely with Clinical Operations in efficient execution of the phase IV study program,
- Provide medical expertise and editorial support in the data dissemination from clinical and non-interventional studies at conferences and in medical journals
- Provide support to the HEOR team for non-interventional studies
- Establish appropriate strategic partnerships with centers of excellence and KOLs in areas of scientific interest
- Plan and develop content for advisory board meetings with opinion leaders on data generation strategies
- Serve as Medical Affairs representative on cross-functional teams supporting phase 2/3 pipeline products
Education/Experience/Skills:
M.D., D.O., or equivalent degree
10 years minimum experience in the biotech or pharmaceutical industry
Experience with hands on management of P IV clinical trials