Remote Director, Late-Stage Clinical Strategy

Definium Therapeutics; United States; Remote; USD 215,000 - 250,000; Full time

Benefits offered by this job

Health benefits for you and dependents

401(k) with company match

Generous paid time off

Job summary

Definium Therapeutics is a late-stage biopharmaceutical company focused on psychiatry and psychedelics. We seek a Director of Late-Stage Clinical Development to lead end‑to‑end strategy for Expanded Access Programs and late-stage studies while driving regulator-ready programs and lifecycle management.

The role requires strategic leadership and hands-on execution in a fast-paced, remote setting, with collaboration across Clinical Development, Regulatory, HEOR, and Commercial teams.

Qualifications

• PhD/MD/PharmD/PsyD required with pharma/biotech experience.
• 6–8+ years in clinical development, especially late-stage or post-approval programs.
• Experience leading Expanded Access programs.
• Ability to manage third-party vendors and regulatory coordination.

Responsibilities

• Define and execute global strategy for Expanded Access Programs and late-stage development.
• Lead protocol development, safety oversight, and operational execution of EAPs.
• Design and implement late-stage evidence programs including real-world data generation.
• Collaborate across functions to meet regulatory, payer, and scientific needs.

Skills

Cross-functional leadership

Strategic thinking

Scientific rigor

Regulatory strategy

Communication skills

Education

Doctoral degree (MD/PhD/PharmD/PsyD)

Tools

Vendor management

Job description

Definium Therapeutics is a late-stage biopharmaceutical company focused on psychiatry and psychedelics. We seek a Director of Late-Stage Clinical Development to lead end‑to‑end strategy for Expanded Access Programs and late-stage studies while driving regulator-ready programs and lifecycle management.

The role requires strategic leadership and hands-on execution in a fast-paced, remote setting, with collaboration across Clinical Development, Regulatory, HEOR, and Commercial teams.