Senior Director of Clinical Development

Job Summary

To advance late-stage clinical strategies, the full-time Senior Director of Clinical Development will manage the end-to-end strategy development, design, and execution of Expanded Access Programs and Late-Stage studies in a remote capacity.

Key responsibilities

• Lead the global strategy for Expanded Access Programs and Late-Stage development, ensuring alignment with asset lifecycle objectives and regulatory expectations
• Oversee the development and implementation of Expanded Access Programs, including protocol development and operational execution
• Support the design and execution of potential Phase 4 studies, ensuring compliance with regulatory commitments and scientific gaps are addressed

Required qualifications

• Doctoral degree required (MD, PhD, PharmD, PsyD)
• 8+ years of clinical development experience in the pharmaceutical or biotechnology industry
• Demonstrated experience leading late-stage, post-approval, or Expanded Access programs
• CNS development experience (psychiatry or neurology) strongly preferred
• Experience in small molecule development preferred