Director, Late-Stage Clinical Strategy & Expanded Access

Psychedelic Alpha; Myrtle Point (OR); On-site; USD 215,000 - 250,000; Full time

Benefits offered by this job

Health benefits (medical, dental, vis­

401(k) with company match

Generous PTO and parental leave

Job summary

Definium Therapeutics is seeking a Director of Late‑Stage Clinical Strategy to shape end‑to‑end Expanded Access and late‑stage programs across our portfolio. You will partner with Clinical Development, Regulatory, and Operations to ensure feasibility, regulatory readiness, and lifecycle alignment while guiding external collaborations with investigators and partners.

You will drive long‑term evidence generation, real‑world data plans, and post‑approval commitments, balancing strategic vision with

Qualifications

• Doctoral degree required (MD, PhD, PharmD, PsyD).
• 6–8+ years of clinical development experience in pharma/biotech.
• Proven experience leading Expanded Access and late‑stage programs.
• Experience managing third‑party vendors for program operations.
• CNS psychiatry experience strongly preferred.

Responsibilities

• Lead end‑to‑end strategy for Expanded Access Programs and late‑stage studies.
• Ensure programs are scientifically sound, regulator‑ready, and lifecycle aligned.
• Provide leadership across regulatory, clinical development, and operations.
• Collaborate with cross‑functional teams to ensure high‑quality execution.
• Engage external investigators and advisors to support objectives.

Skills

Expanded Access

Late-stage strategy

Cross-functional leadership

Regulatory strategy

Clinical operations

External engagement

Education

Doctoral degree

Job description

Definium Therapeutics is seeking a Director of Late‑Stage Clinical Strategy to shape end‑to‑end Expanded Access and late‑stage programs across our portfolio. You will partner with Clinical Development, Regulatory, and Operations to ensure feasibility, regulatory readiness, and lifecycle alignment while guiding external collaborations with investigators and partners.

You will drive long‑term evidence generation, real‑world data plans, and post‑approval commitments, balancing strategic vision with