Associate Director, Clinical Quality (Remote Eligible)

Denali Therapeutics; South San Francisco (CA); Remote; USD 171,000 - 223,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Broad range of benefits

Job summary

Denali Therapeutics in South San Francisco seeks a seasoned GCP Quality Leader to oversee the global clinical trial portfolio, anchor inspection readiness, and drive continuous improvement of the GCP Quality Management System.

You will lead quality risk management, sponsor inspections, oversight of CROs and vendors, and shape scalable quality processes across development stages, ensuring compliance, ethics, and patient safety.

Qualifications

• 12+ years of related experience with a Bachelor's degree, or equivalent.
• Experience building, implementing, or improving Quality Management Systems.
• Working knowledge of ICH E6 GCP guidelines, FDA CFR, and global regulations.
• Demonstrated experience supporting or leading regulatory inspections (FDA, EMA, MHRA or other authorities).
• Experience providing quality oversight of CROs, vendors, labs and outsourced services.

Responsibilities

• Lead GCP quality strategy for assigned Study Execution Teams.
• Partner with site leadership and cross-functional teams to mature site-level quality.
• Lead proactive quality risk assessments and mitigation strategies.
• Own risk-based monitoring and analysis of quality issues with strong regulatory alignment.
• Lead Sponsor inspection strategy and inspection management.
• Identify gaps, conduct root cause analyses, and drive CAPA effectiveness.
• Oversee CAPA implementation and continuous improvement activities.
• Lead QA oversight of CROs and vendors across development lifecycle.
• Design and improve GCP QA processes, SOPs, and quality systems.

Skills

GCP quality oversight

Regulatory inspections

QMS implementation

ICH GCP knowledge

Cross-functional leadership

Vendor oversight

Quality risk management

Education

Bachelor's degree

Tools

GCP QA tools

Job description

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.

Key Accountabilities/Core Job Responsibilities

• 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 assessments and drive risk mitigation strategies throughout study execution.
• Own risk-based monitoring and analysis of quality issues, delivering strategic guidance aligned with ICH-GCP and applicable global regulations.
• Lead Sponsor inspection strategy, inspection management, regulatory interactions, inspection response activities, and CAPA effectiveness.
• Identify quality and compliance gaps, direct root cause analysis, and drive CAPA development to resolution.
• Oversee CAPA implementation, effectiveness reviews, and continuous improvement activities.
• Lead evaluation, selection, and ongoing quality oversight of CROs and clinical vendors.
• Design and continuously improve GCP Quality Systems, SOPs, and the broader Quality Management System.
• Lead development of inspection strategy documents, study storyboards, and inspection readiness tools.
• Own QA review of essential clinical trial documents and lead implementation of internal GCP QA processes and tools.
• Represent Clinical Quality Assurance in cross-functional initiatives, championing a culture of compliance, ethics, and patient safety across clinical programs.

Qualifications/Skills

• 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.
• Experience implementing ICH E6(R3) Quality by Design and Quality Risk Management principles.
• Excellent communication and presentation skills with demonstrated ability to communicate complex quality issues to senior leadership and regulatory inspectors.
• Strong critical-thinking skills, with the ability to synthesize complex, ambiguous information from multiple sources to drive resolution.

Salary Range

$171,000.00 to $223,000.00.

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.

• 401k
• healthcare coverage
• ESPP
• broad range of other benefits

Equal Opportunity Statement

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

"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.