Director, Late Stage Clinical Development

Responsibilities

• Lead global strategy for Expanded Access Programs and Late-Stage development
• Develop and implement Expanded Access Programs including protocol development and safety oversight
• Support late-stage clinical evidence generation strategy including real-world evidence and long-term safety
• Design and execute late-stage clinical evidence programs for Phase 4 and investigator-initiated trials
• Collaborate on clinical content for regulatory submissions and Investigator Brochures
• Partner with cross-functional teams including Clinical Operations, Regulatory Affairs, and Medical Affairs
• Establish relationships with key investigators and external experts

Requirements

• Doctoral degree required (MD, PhD, PharmD, PsyD)
• 6-8+ years of clinical development experience in the pharmaceutical or biotechnology industry
• Demonstrated experience leading Expanded Access programs and late-stage, post-approval programs
• Experience selecting and managing third-party vendors
• CNS clinical development experience in psychiatry strongly preferred
• Experience with budget ownership including forecasting and tracking

Preferred Qualifications

• CNS clinical development experience in psychiatry
• Proven ability to translate strategy into execution in resource-constrained environments
• Ability to influence without authority and command credibility with senior leaders

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match
• Flexible time off
• Generous parental leave