# Executive Director, Clinical Regulatory - Rare Diseases at Denali Therapeutics

- Company: Denali Therapeutics
- What the company does: Denali Therapeutics brings the power of biotherapeutics to the whole body, including the brain. We discover, develop and deliver medicines for people living with serious diseases. Backed by GV.
- Company website: https://www.denalitherapeutics.com
- Type: Startups
- Level: Principal and up
- Location: South San Francisco
- Work setup: On-site
- Posted: 2026-09-30
- Apply by: 2026-11-14
- Apply: https://dnli.wd1.myworkdayjobs.com/en-US/Development/job/South-San-Francisco/Executive-Director--Clinical-Regulatory---Rare-Diseases_R-1682?utm_source=1752vc&utm_medium=careers
- Page: https://www.1752.vc/careers/jobs/denali-therapeutics-executive-director-clinical-regulatory-rare-diseases/

## About the role

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. Found on 1752vc Careers, the job board for startup and VC roles.

## What they're looking for

- Bachelor's degree in a life science or related field required, advanced degree in life sciences (PhD, PharmD, MD, or MS) strongly preferred
- Demonstrated success leading global regulatory strategy across a multi-program portfolio, including direct leadership of FDA and EMA interactions and at least one marketing application (BLA/MAA) through approval
- Proven ability to lead through ambiguity and translate scientific, clinical, and cross-therapeutic-area insight into practical, defensible regulatory strategy
- Strong executive presence and communication skills, with demonstrated success presenting regulatory strategy and risk to boards, executive committees, and Health Authorities
- Deep familiarity with FDA, including current review division trends, policy direction, and ways of working, and the ability to anticipate how these will shape rare disease development and approval
- Familiarity with the use of AI tools for research, regulatory intelligence, and strategy development, and openness to adopting new technologies and ways of working


Source: 1752vc Careers, https://www.1752.vc/careers/jobs/denali-therapeutics-executive-director-clinical-regulatory-rare-diseases/