MindMed

Compensation

Full Description

Job Description: • Own and lead the global strategy for Expanded Access Programs and Phase 4 development • 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 collaboratively 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 Requirements: • Doctoral degree required (MD, PhD, PharmD, PsyD) • 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 Benefits: • 100% paid health benefits including Medical, Dental and Vision for you and your dependents • 401(k) program with company match and immediate vesting • Flexible time off • Generous parental leave and some fun fringe perks!