Definium Therapeutics · 2 weeks ago
Executive Director, Expanded Access and Late Stage Clinical Strategy
United States
Full-time
Remote
Director/Executive
$248K/yr - $297K/yr
10+ years expDefinium Therapeutics is a clinical stage biopharmaceutical company focused on developing innovative treatments for brain health disorders. The Executive Director, Expanded Access & Late Stage Clinical Strategy will lead the strategy and execution of Expanded Access Programs and late-stage studies, ensuring alignment with regulatory and operational standards while collaborating with various departments to integrate clinical activities into the overall asset strategy.
Biotechnology
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
Qualification
Required
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
Preferred
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 vesting after the turn of the first month after your start date
Flexible time off
Generous parental leave and some fun fringe perks!
Company
Definium Therapeutics
Definium Therapeutics (formerly MindMed) is a biotech company forging a new era of psychiatry by applying precision to psychedelic medicine.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase