Director of Late Stage Clinical Development

Job Summary

To support the development of innovative psychiatric treatments, the full-time remote Director of Late Stage Clinical Development will manage the end-to-end strategy, design, and execution of Expanded Access Programs and Late-Stage studies, ensuring alignment with regulatory and operational goals.

Key responsibilities

• Lead the global strategy for Expanded Access Programs and Late-Stage development, ensuring integration with asset lifecycle objectives
• Oversee the development and implementation of Expanded Access Programs, including protocol development and operational execution
• Support the design and execution of late-stage clinical evidence generation strategies, addressing regulatory commitments and payer needs

Required qualifications

• Doctoral degree (MD, PhD, PharmD, PsyD) required
• 6-8+ years of clinical development experience in the pharmaceutical or biotechnology industry
• Demonstrated experience leading Expanded Access programs and late-stage clinical programs
• CNS clinical development experience in psychiatry strongly preferred
• Experience managing third-party vendors for operational functions of clinical programs