Director, Late Stage Clinical Development

Definium Therapeutics

4d • $215,000 - $250,000

About The Position

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric and neurological disorders by applying scientific rigor to psychedelics. Our lead product candidate, lysergide tartrate, targets generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our pipeline also includes DT402, for the core symptoms of autism spectrum disorder. We aim to address the underlying causes of these disorders and change the trajectory of mental health care. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. We are looking for individuals to join us in moving psychiatry forward.

Requirements

• Doctoral degree required (MD, PhD, PharmD, PsyD)
• 6-8+ years of clinical development experience in the pharmaceutical or biotechnology industry
• Demonstrated experience leading Expanded Access programs and late‑stage, post‑approval programs
• Experience selecting and managing third-party vendors to support operational functions of Expanded Access and late-stage evidence programs
• Experience with budget ownership to include forecasting tracking, and managing across multiple programs
• Working knowledge of expanded access program requirements, 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

Nice To Haves

• CNS clinical development experience in psychiatry strongly preferred

Responsibilities

• Lead aspects of 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 Executive Director Late-Stage Clinical Strategy, Clinical Development, Clinical Operations, HEOR, Medical Affairs, Regulatory Affairs, Commercial, Asset Strategy Lead and Program Leadership to ensure Expanded Access Program and Late-Stage clinical activities are fully integrated into the overall asset strategy.
• Lead the development and implementation of Expanded Access Programs, including protocol development, eligibility criteria, safety oversight, and operational execution.
• Collaborate with cross‑functional planning team to ensure Expanded Access Programs are compliant, scalable, ethically sound, and aligned with regulatory guidance.
• Provide consultation to benefit–risk assessment, safety monitoring, and ongoing program evaluation.
• Support the development of the late-stage clinical evidence generation strategy objectives, including real‑world evidence generation, long‑term safety, effectiveness, and differentiation in the treatment landscape.
• Lead the design, planning, and execution of the late-stage clinical evidence program, including protocol development, data collection strategies, and interpretation of outcomes for Phase 4 and investigator-initiated trials.
• Ensure late-stage clinical program designs address regulatory commitments, payer needs, and scientific gaps.
• Collaborate in the preparation and review of clinical content for regulatory submissions and interactions as applicable.
• Provide clinical input into Investigator Brochures, clinical study reports, in collaboration with Regulatory Affairs.
• Work collaboratively with Clinical Operations, Clinical Development, 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
• some fun fringe perks!

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree