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MindMed · 1 day ago

Executive Director, Expanded Access and Phase 4 Clinical Strategy

Durham, NC

Full-time

Onsite

Director/Executive

$248K/yr - $297K/yr

10+ years exp

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. The Executive Director, Expanded Access & Phase 4 Clinical Strategy will be responsible for the end-to-end strategy, design, and execution of Expanded Access Programs and Phase 4 studies, ensuring they are scientifically sound and operationally feasible.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

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 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

Qualification

Clinical development experienceRegulatory pathways knowledgeExpanded Access ProgramsPhase 4 programs experienceCNS development experienceSmall-molecule developmentStakeholder engagementCross-functional leadershipCommunication skillsSelf-motivatedAdaptable