# Associate Director, Risk Management 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: 2026-08-25
- Apply by: 2026-10-09
- Apply: https://dnli.wd1.myworkdayjobs.com/en-US/Development/job/South-San-Francisco/Associate-Director--Risk-Management_R-1621
- Page: https://www.1752.vc/careers/jobs/denali-therapeutics-associate-director-risk-management/

## About the role

Lead the GCP deviation and CAPA processes, ensuring timely investigation, implementation, effectiveness verification, and closure. Partner with study teams to identify, assess, and mitigate quality risks across clinical development programs using Quality by Design and risk-based quality management principles.

## What they're looking for

- Demonstrated expertise in ICH E6 Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), FDA regulations, and other applicable global regulatory requirements
- Experience applying Quality by Design (QbD), Risk-Based Quality Management (RBQM), and Quality Management System (QMS) principles within clinical development
- Experience leading GCP deviation, CAPA, vendor qualification, and quality risk management processes in a GxP-regulated environment
- Strong analytical and critical thinking skills with the ability to evaluate complex quality risks, identify trends, and develop practical, risk-based solutions
- Excellent written, verbal, and interpersonal communication skills with demonstrated ability to influence and collaborate across cross-functional teams without direct authority
- Ability to manage multiple priorities in a dynamic, fast-paced environment while maintaining a high level of quality, accuracy, and attention to detail