Senior Director, Clinical Quality

Denali Therapeutics•South San Francisco, CA

4d•$245,000 - $318,000

About The Position

Denali Therapeutics is seeking a Senior Director, Clinical Quality to safeguard the scientific and regulatory integrity of its clinical development portfolio. The role leads enterprise-wide GCP and GCLP quality strategy across functions engaged in clinical research, sets the vision for Denali’s clinical Quality Management System, drives inspection readiness, and builds the team and processes needed to scale quality oversight as the portfolio grows. The Senior Director leads and develops the Clinical Quality organization, owns the GCP/GCLP audit program, and oversees quality governance and documentation practices. The role partners with Regulatory Affairs, Clinical, Clinical Operations, and IT leadership to address enterprise-level risks and align quality strategy with program execution. It also provides quality metrics and risk assessments to senior management and serves as the executive point of contact during Sponsor and Health Authority inspections.

Requirements

Bachelor's degree typically required.
12+ years of relevant GCP/quality experience.
10+ years of people management experience.
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 them 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.
Experience managing and developing a team of quality professionals.

Nice To Haves

Advanced degree in a health/science-related discipline.

Responsibilities

Set enterprise-wide GCP/GCLP compliance strategy and quality vision, translating regulatory and business priorities into a risk-based Quality Management System across clinical functions.
Lead and develop the Clinical Quality organization, including subordinate managers/directors, through goal setting, growth planning, and performance feedback.
Own the GCP/GCLP audit program and direct audit strategy across CRO/vendor, laboratory, investigational site, and documentation audits.
Escalate and resolve enterprise-level quality risks in partnership with Regulatory Affairs, Clinical, Clinical Operations, and IT leadership.
Drive GCP/GCLP CAPA and Deviation governance, ensuring systemic issues are identified and resolved at the functional level.
Direct GCP QA oversight of the eTMF and ensure 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 senior management.
Lead organizational preparation for Sponsor and Health Authority inspections and serve as the executive point of contact during inspections.