Senior Director, Clinical Quality

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 245,000 - 318,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Broad benefits package

Job summary

Denali Therapeutics Inc. is seeking a senior leader to safeguard the clinical development portfolio's quality by directing enterprise GCP/GCLP quality strategy.

You will lead the Clinical Quality organization, manage audit programs across CROs and sites, and ensure inspection readiness through a scalable QMS. This role centers on risk-based quality oversight and collaboration with Regulatory Affairs and IT leadership.

Qualifications

• Typically requires a Bachelor’s degree with 12+ years of relevant GCP/quality experience, including 10+ years of people management experience.
• Expert knowledge of ICH E6(R2) GCP guidelines and FDA CFR, with ability to interpret across functions.
• Demonstrated experience building and scaling clinical QMS and audit programs in biotech/pharma.
• Proven track record leading regulatory inspections and Health Authority interactions.

Responsibilities

• Set enterprise-wide GCP/GCLP compliance strategy and quality vision across clinical functions.
• Lead and develop Clinical Quality organization and manage senior staff.
• Own the GCP/GCLP audit program across CRO/vendor, labs, sites, and documentation audits.
• Escalate and resolve enterprise-level quality risks with cross-functional partners.
• Drive CAPA and Deviation governance for systemic issue resolution.
• Oversee GCP QA for eTMF and inspection-ready documentation.
• Lead development and enterprise-wide implementation of Quality SOPs.
• Provide quality metrics and risk assessments to senior management.
• Prepare for Sponsor and Health Authority inspections as executive point of contact.

Skills

GCP/QA leadership

People management

Regulatory inspections

Cross-functional collaboration

Risk-based QMS

Education

Bachelor's degree in health/science

Advanced degree preferred

Tools

Audit management software

Quality management systems

Job description

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. 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.

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.

Salary Range: $245,000.00 to $318,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.

Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

“Life at Denali” is a living reflection of our values: trust, unity, grit and growth. These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.