Executive Director, Expanded Access and Phase Clinical Strategy

Role Summary

The Executive Director, Expanded Access & Phase 4 Clinical Strategy will be accountable for the end‑to‑end strategy, design, and execution of Expanded Access Programs and Phase 4 studies across Definium's portfolio. This leader will ensure programs are scientifically sound, operationally feasible, regulator‑ready, and aligned with the integrated asset strategy, including lifecycle management, real‑world evidence generation, and post‑approval commitments. This role requires both strategic leadership and hands‑on execution, with the ability to operate effectively in a lean, fast‑moving organization.

• Own and lead the global strategy for Expanded Access Programs and Phase 4 development, aligned with asset lifecycle objectives, patient access goals, and regulatory expectations
• Partner with the CMO, Clinical Development, Medical Affairs, Regulatory Affairs, Commercial, Asset Strategy Lead and Program Leadership to ensure EAP and Phase 4 activities are fully integrated into the overall asset strategy and Target Product Profile (TPP)
• Serve as the clinical development lead for governance discussions related to post‑approval and access strategies, clearly articulating risks, trade‑offs, and recommendations
• Design and implement Expanded Access Programs, including protocol development, eligibility criteria, safety oversight, and operational execution
• Lead cross‑functional planning to ensure EAPs are compliant, scalable, ethically sound, and aligned with regulatory guidance
• Provide clinical leadership for benefit–risk assessment, safety monitoring, and ongoing program evaluation
• Define Phase 4 objectives, including real‑world evidence generation, long‑term safety, effectiveness, and differentiation in the treatment landscape
• Lead the design, planning, and execution of Phase 4 studies, including protocol development, data collection strategies, and interpretation of outcomes
• Ensure Phase 4 programs address regulatory commitments, payer needs, and scientific gaps
• Lead preparation and review of clinical content for regulatory submissions and interactions as applicable
• Act as a clinical subject matter expert in interactions with U.S. and ex‑U.S. health authorities related to Expanded Access and Phase 4 activities
• Oversee clinical input into Investigator Brochures, clinical study reports, in collaboration with Regulatory Affairs
• Work collaborativ ely with Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, and Project Management to ensure high‑quality execution
• Establish and maintain relationships with key investigators, advisors, and external experts to support EAP and Phase 4 objectives
• Provide clinical leadership within matrix teams, modeling accountability, collaboration, and scientific rigor

• 10+ years of clinical development experience in the pharmaceutical or biotechnology industry
• Demonstrated experience leading late‑stage, post‑approval, Expanded Access, and/or Phase 4 programs
• CNS development experience (psychiatry or neurology) strongly preferred
• Experience in small‑molecule development preferred

• Doctoral degree required (MD, PhD, Pharm
  
  D, PsyD)

• Deep understanding of clinical development, regulatory pathways, and lifecycle management
• Proven ability to translate strategy into execution in resource‑constrained environments
• Track record of effective cross‑functional leadership and external stakeholder engagement
• Ability to operate with diplomacy, influence without authority, and command credibility with senior leaders and external experts
• Excellent verbal and written communication skills
• Self‑motivated, adaptable, and comfortable balancing strategic thinking with hands‑on contribution