Senior Director, Clinical Quality
Denali Therapeutics
Summary
This role safeguards the scientific and regulatory integrity of Denali's clinical development portfolio by leading enterprise-wide GCP and GCLP quality strategy across all functions engaged in clinical research. It sets the vision and direction for Denali's clinical Quality Management System, drives inspection readiness across the organization, and builds the team and processes needed to scale quality oversight as the clinical portfolio grows.
Job description
Key Accountabilities / Core Job Responsibilities:
- Set enterprise-wide GCP/GCLP compliance strategy and quality vision, translating regulatory and business priorities into a risk-based Quality Management System spanning all clinical functions.
- Lead and develop the Clinical Quality organization, managing subordinate managers/directors and providing goal setting, growth planning, and performance feedback for the team.
- Own the GCP/GCLP audit program, directing audit strategy across CRO/vendor, laboratory, investigational site, and documentation audits.
- Escalate and resolve enterprise-level quality risks, partnering with Regulatory Affairs, Clinical, Clinical Operations, and IT leadership to align quality strategy with program execution.
- Drive the GCP/GCLP CAPA and Deviation governance process, ensuring systemic issues are identified and resolved at the functional level.
- Direct GCP QA oversight of the eTMF, ensuring inspection-ready documentation practices across the portfolio.
- Lead development and enterprise-wide implementation of Quality SOPs.
- Provide GCP/GCLP quality metrics and strategic risk assessments to Denali senior management.
- Lead organizational preparation for Sponsor and Health Authority inspections, serving as the executive point of contact during inspections.
Qualifications/Skills:
- Typically requires a Bachelor's degree with 12+ years of relevant GCP/quality experience, including 10+ years of people management experience; advanced degree in a health/science-related discipline preferred.
- Expert knowledge of ICH E6(R2) GCP guidelines, FDA Code of Federal Regulations, and other global clinical research regulations, with demonstrated ability to interpret and apply these across functions.
- Demonstrated experience building and scaling clinical Quality Management Systems and audit programs in a biotech/pharmaceutical setting.
- Proven track record leading regulatory inspections and Health Authority interactions.
- Strong leadership, communication, and cross-functional influence skills, with experience managing and developing a team of quality professionals.
Requirements
- Bachelor's degree with 12+ years of relevant GCP/quality experience
- 10+ years of people management experience
- Expert knowledge of ICH E6(R2) GCP guidelines
- Expert knowledge of FDA Code of Federal Regulations
- Expert knowledge of global clinical research regulations
- Demonstrated experience building and scaling clinical Quality Management Systems
- Demonstrated experience building and scaling audit programs in biotech/pharma
- Proven track record leading regulatory inspections
- Proven track record leading Health Authority interactions
- Strong leadership, communication, and cross-functional influence skills
- Experience managing and developing a team of quality professionals
Benefits
- 401(k)
- Healthcare coverage
- ESPP
Company overview
Denali Therapeutics is a pioneering biotechnology company focused on developing innovative therapeutics for neurodegenerative and lysosomal storage diseases. Founded in 2015 and headquartered in South San Francisco, California, the company has developed a proprietary TransportVehicle™ (TV) platform designed to enable biotherapeutics to cross the blood-brain barrier, addressing one of the most significant challenges in treating central nervous system disorders. Denali's pipeline includes promising candidates for conditions such as Hunter syndrome (MPS II), Parkinson's disease, frontotemporal dementia, Sanfilippo syndrome (MPS IIIA), and MPS I, with several programs in advanced clinical development stages. The company collaborates with major pharmaceutical partners including Biogen and Sanofi, leveraging its platform technology to create a new class of barrier-crossing therapeutics. With approximately 500-1,000 employees and operations spanning multiple locations including Salt Lake City, Denali Therapeutics represents a leading force in neuroscience drug development, combining deep scientific expertise with a patient-centric approach to transform treatment paradigms for serious neurological conditions.