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.
About the role
Lead GCP quality strategy on assigned Study Execution Teams (SETs), establishing a cohesive framework across Denali's clinical trials. Partner with the Zurich Site Lead and cross-functional leaders to drive site-level quality maturity and operational excellence.
What they're looking for
- Typically requires 12+ years of related experience with a Bachelor's degree, or relevant combination of degree and experience
- Experience developing, implementing, or improving Quality Management Systems
- Working knowledge of ICH E6 GCP guidelines, FDA Code of Federal Regulations, and other applicable global regulations
- Demonstrated experience supporting or leading regulatory inspections (FDA, EMA, MHRA or other global regulatory authorities)
- Demonstrated experience providing quality oversight of CROs, vendors, laboratories, and other outsourced clinical service providers
- Demonstrated ability to influence cross-functional teams and lead strategic quality initiatives in a matrix organization
More about this role
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
This role delivers strategic GCP quality oversight across Denali's clinical trial portfolio, anchoring inspection readiness, risk-based quality decision-making, and continuous improvement of the GCP Quality Management System. Providing strategic leadership in quality risk management, inspection readiness, Sponsor oversight, and continuous improvement across the clinical development lifecycle. It sets the standard for compliance and ethical conduct across study teams, site leadership, and external partners, translating regulatory expectations into practical, scalable quality processes. The role shapes how Denali's quality systems evolve as the clinical portfolio grows, exercising independent judgment on complex, ambiguous compliance matters with limited precedent.
Lead GCP quality strategy on assigned Study Execution Teams (SETs), establishing a cohesive framework across Denali's clinical trials.
Partner with the Zurich Site Lead and cross-functional leaders to drive site-level quality maturity and operational excellence.
Lead proactive quality risk...
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