Director, Late-Stage Clinical Strategy & Access

Definium Therapeutics; Durham (NC); On-site; USD 215,000 - 250,000; Full time

Benefits offered by this job

100% paid health benefits (Medical, D‑

401(k) with company match

Flexible time off

Generous parental leave

Job summary

Definium Therapeutics seeks a Director of Late-Stage Clinical Strategy to lead end‑to‑end Expanded Access Programs and late‑stage studies across our portfolio.

You will provide strategic leadership and hands‑on execution in a lean, fast‑moving organization, collaborating with Clinical Development, Regulatory Affairs, HEOR, Medical Affairs, and Commercial teams.

The role is based in the United States with a base pay range and opportunities for bonus and equity.

Qualifications

• Doctoral degree and 6–8+ years of clinical development experience.
• Experience leading Expanded Access and late‑stage programs.
• Strong cross‑functional leadership and external stakeholder engagement.
• Excellent verbal and written communication; strategic yet hands‑on.

Responsibilities

• Lead global strategy for Expanded Access Programs and late‑stage development.
• Oversee protocol development, eligibility criteria, safety oversight, and execution.
• Coordinate with Regulatory, Clinical Development, and Commercial teams to align strategies.
• Provide clinical input for regulatory submissions and study reports.
• Foster relationships with investigators and external experts to support program goals.

Skills

Strategic leadership

Cross-functional leadership

Regulatory pathways

External stakeholder engagement

Verbal and written communication

Strategic execution

Education

Doctoral degree

Job description

Definium Therapeutics seeks a Director of Late-Stage Clinical Strategy to lead end‑to‑end Expanded Access Programs and late‑stage studies across our portfolio.

You will provide strategic leadership and hands‑on execution in a lean, fast‑moving organization, collaborating with Clinical Development, Regulatory Affairs, HEOR, Medical Affairs, and Commercial teams.

The role is based in the United States with a base pay range and opportunities for bonus and equity.