Associate Director, Risk Management

Denali Therapeutics•South San Francisco, CA

2d•$171,000 - $223,000

About The Position

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. 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.

Requirements

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.

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.