Director, Late Stage Clinical Development

Role: Lead the development and execution of strategies for Expanded Access Programs and late-stage clinical studies within a psychiatric biopharma context, focusing on psychedelics and neuropsychiatric therapeutics. Responsibilities: develop integrated global strategies, oversee protocol design, safety, and operational implementation of access programs, and support evidence generation for post-approval indications. Collaborate across functions such as Clinical Operations, Data Management, Regulatory, and Medical Affairs to ensure regulatory compliance, scientific rigor, and alignment with lifecycle management goals. Provide clinical input for regulatory submissions and external stakeholder engagement, including investigators and advisors. Requirements: Doctoral degree (MD, PhD, PharmD, PsyD); 6-8+ years in clinical development, with proven experience in leading advanced access and late-stage programs—preferably in CNS or psychiatry. Skills include knowledge of regulatory pathways, lifecycle management, vendor management, and cross-functional leadership. Preferred: CNS clinical development experience. High-Value: focus on psychiatric indications such as generalized anxiety, MDD, PTSD, and ASD; oversight of Phase 4 and post-approval studies; deep understanding of real-world evidence and regulatory strategy. WorkSetup: Not specified.