Senior Director, Clinical Quality

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

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics Inc. is seeking a Senior Director, Clinical Quality to safeguard scientific and regulatory integrity across the clinical portfolio. You will set the GCP/GCLP quality strategy, drive inspection readiness, and scale the quality organization to support growth across functions.

You will lead audit programs, CAPA governance, and eTMF oversight, while mentoring managers and partnering with Regulatory Affairs, Clinical Operations and IT to align quality with program goals.

Qualifications

• Bachelor’s degree with 12+ years of GCP/quality experience.
• 10+ years of people management experience.
• Advanced degree in health/science-related discipline preferred.
• Expert knowledge of ICH E6(R2) GCP guidelines, FDA CFR, and other global regulations.

Responsibilities

• Set enterprise-wide GCP/GCLP compliance strategy and quality vision across clinical functions.
• Lead and develop the Clinical Quality organization and manage senior staff.
• Own the GCP/GCLP audit program across CROs, labs, sites, and documentation.
• Escalate and resolve enterprise-level quality risks with Regulatory Affairs and IT leadership.
• Drive CAPA and Deviation governance to address systemic issues.
• Oversee eTMF quality to ensure inspection-ready documentation.
• Lead development and enterprise-wide SOP implementation.
• Provide quality metrics and risk assessments to senior management.
• Prepare for Sponsor and Health Authority inspections as executive point of contact.

Skills

GCP expertise

ICH E6(R2) knowledge

Regulatory inspections

Quality leadership

Audit programs

Cross-functional influence

Education

Bachelor’s degree in health/science

Advanced degree preferred

Job description

Senior Director, Clinical Quality### Senior Director, Clinical QualityApply: South San Francisco: Full time: Posted Yesterday: R-1674Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicleTM 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/careersThis 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.