Associate Director, Clinical Quality (Remote Eligible)

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.

Pay

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.

Benefits

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.