Note: The job is a remote job and is open to candidates in USA. Definium Therapeutics is a late-stage clinical biopharmaceutical company developing psychedelic-based treatments for psychiatric and neurological disorders. The Director, Late-Stage Clinical Strategy will lead the strategy, design, and execution of Expanded Access Programs and late-stage clinical evidence programs, ensuring scientific rigor, operational feasibility, regulatory readiness, and alignment with asset lifecycle objectives.
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
Skills
- 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
- 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
- CNS clinical development experience in psychiatry strongly preferred
Benefits
- Employees in this role may be entitled to additional compensation, including bonus and equity.
- 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
Company Overview