Executive Director, Expanded Access and Late Stage Clinical Strategy
About The Position
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals. The Executive Director, Expanded Access & Late Stage Clinical Strategy will be accountable for the end‑to‑end strategy, design, and execution of Expanded Access Programs and Late Stage 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.
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 later stage programs
- 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
- Comfortable rolling up sleeves while maintaining a strategic perspective
- Energized by innovation in clinical research and patient‑centric access models
- Thrives in a fast‑paced, evolving environment with high accountability
- Acts as a role model for scientific excellence, integrity, and collaboration
Nice To Haves
- CNS development experience (psychiatry or neurology) strongly preferred
- Experience in small‑molecule development preferred
Responsibilities
- Own and lead the global strategy for Expanded Access Programs and Late Stage 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 Late Stage clinical 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 potential phase 4 objectives and lead the design, plan and execution of potential phase 4 studies, ensure potential phase 4 program objectives, including real‑world evidence generation, long‑term safety, effectiveness, and differentiation in the treatment landscape
- Lead the design, planning, and execution of late stage and prepare for the possibility of Phase 4 studies, including protocol development, data collection strategies, and interpretation of outcomes
- Ensure late stage and any potential Phase 4 program design 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 Late Stage 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 late stage/potentially Phase 4 objectives
- Provide clinical leadership within matrix teams, modeling accountability, collaboration, and scientific rigor
Benefits
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave and some fun fringe perks!
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
