Associate Director, Regulatory Project Manager
Denali Therapeutics
September 01, 2026
Full-time
Remote friendly (South San Francisco, CA)
Worldwide
Corporate Functions
Role: Lead regulatory planning and strategy to ensure timely progression of neurodegenerative disease therapeutics from IND/CTA to BLA/NDA/MAA stages. Responsibilities: develop and manage regulatory timelines, align cross-functional teams, oversee external vendor collaborations, mitigate risks, support health authority interactions, and shape regulatory resource planning and initiatives. Qualifications: minimum 12 years of experience with a Bachelor's, or 10 years with a Masterβs, or 7 years with a PhD, plus 5+ years in project/program management, especially with INDs/CTAs and marketing authorizations; proficiency in project management tools like Smartsheet. Preferred: experience with rare disease or complex filings. HighValue: focus on neurodegenerative diseases, regulatory strategy, cross-functional leadership, risk management, and strategic initiatives. WorkSetup: not specified; salary range $171K-$223K, with comprehensive benefits.