Executive Director – Expanded Access and Phase 4 Clinical Strategy
MindMed
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $248,140 - $296,656 per year
Job Level
About the role
- 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!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical developmentExpanded Access ProgramsPhase 4 developmentprotocol developmentsafety monitoringreal-world evidence generationdata collection strategiesregulatory submissionsbenefit-risk assessmentsmall-molecule development
Soft skills
leadershipcollaborationaccountabilitycommunicationscientific rigorcross-functional planningrelationship managementstrategic thinkingrisk assessmentproblem-solving
Certifications
Doctoral degree (MD, PhD, PharmD, PsyD)