Medical Director, Medical Affairs (Lifecycle Management)

Role: Lead medical affairs in neuroscience late-stage programs, focusing on lifecycle management (LCM) strategies for neurologic and neuropsychiatric indications. Responsibilities: design and oversee clinical trial protocols, serve as LCM program lead, contribute to regulatory documents and external publications, provide medical oversight and data review, develop and communicate LCM and strategic plans, manage Investigator Sponsored Studies and expanded access programs, engage with external stakeholders, and ensure operational and SOP compliance. Qualifications: MD with Neurology or Psychiatry experience, 2+ years in pharma medical affairs or clinical development, experience with global regulatory interactions, sNDA submissions, and label expansions preferred. HighValue: neuroscience (neurology/psychiatry), late-stage clinical programs, sNDA support, lifecycle management, global regulatory interactions, hybrid work environment (60% onsite Waltham, MA). WorkSetup: hybrid; onsite at least 3 days/week.