Associate Director, Risk Management

About the role

Serves as a subject matter expert in Quality Risk Management, partnering with GCP and GVP Quality colleagues and cross-functional development teams to proactively identify, assess, and mitigate quality risks across Denali's clinical development programs. Strengthens quality oversight by driving risk-based decision making, ensuring regulatory compliance, and advancing a culture of continuous improvement. Leads quality risk management processes, metrics, and vendor oversight activities that support inspection readiness and the successful execution of clinical trials.

Key Accountabilities / Core Job Responsibilities

• Lead the GCP deviation and CAPA processes, ensuring timely investigation, implementation, effectiveness verification, and closure.
• Partner with study teams to identify, assess, and mitigate quality risks across clinical development programs using Quality by Design and risk-based quality management principles.
• Serve as the subject matter expert on GCP quality risk management, providing guidance on the detection, investigation, documentation, and resolution of GCP noncompliance.
• Maintain quality oversight of the Clinical Trial Risk Tracking Program and ensure risks are appropriately documented, monitored, and escalated.
• Analyze quality and compliance data, identify trends, develop meaningful metrics, and communicate insights and recommendations to leadership and cross-functional stakeholders.
• Review deviations, noncompliance, and quality events across development programs to identify systemic risks and drive continuous improvement initiatives.
• Lead GCP and GVP vendor qualification and ongoing quality oversight activities to ensure compliance with applicable regulatory requirements and company standards.
• Support regulatory inspections and audits through inspection readiness activities, documentation review, response development, and follow-up actions.
• Contribute to the ongoing enhancement of the Quality Management System (QMS) by improving quality risk management processes, tools, and best practices.

Qualifications / Skills

• Typically requires a Bachelor's degree with 12+ years of relevant GCP Quality Assurance experience, a Master's degree with 10+ years of relevant experience, or a PhD with 7+ years of relevant experience; or an equivalent combination of education and experience.
• Demonstrated expertise in ICH E6 Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), FDA regulations, and other applicable global regulatory requirements.
• Experience applying Quality by Design (QbD), Risk-Based Quality Management (RBQM), and Quality Management System (QMS) principles within clinical development.
• Experience leading GCP deviation, CAPA, vendor qualification, and quality risk management processes in a GxP-regulated environment.
• Strong analytical and critical thinking skills with the ability to evaluate complex quality risks, identify trends, and develop practical, risk-based solutions.
• Excellent written, verbal, and interpersonal communication skills with demonstrated ability to influence and collaborate across cross-functional teams without direct authority.
• Ability to manage multiple priorities in a dynamic, fast-paced environment while maintaining a high level of quality, accuracy, and attention to detail.

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