Associate Director, Clinical Quality
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. The Associate Director, GCP Clinical Quality will play a key role in ensuring the successful execution of Denali’s clinical trials by delivering strategic quality oversight and fostering a culture of compliance and continuous improvement. This position partners cross-functionally across study teams, site leadership, and external partners to uphold high standards of GCP compliance, support inspection readiness, and contribute to the advancement of Denali’s portfolio. The ideal candidate brings a proactive, solution-oriented approach to identifying quality risks, implementing corrective actions, and driving operational excellence across Clinical Development activities.
Requirements
- Bachelor's Degree and 7+ years experience, with 6+ working in GCP QA
- Working knowledge of ICH E6 GCP guidelines, FDA Code of Federal Regulations, and other global applicable laws and regulations
- Experience applying risk-based methodology and working within the QMS framework
- Knowledge of clinical trial systems and processes
- Attention to detail and accuracy in work, while delivering on deadline
- Excellent verbal, written communication, and interpersonal skills
- Work according to procedures, guidelines and regulations
- Critical thinker with ability to synthesize information from multiple sources and apply to problem-solving
- Positive, self-starter and thrives under pressure
- Able to work across multiple projects and prioritize tasks as required
Nice To Haves
- Early phase study support experience desirable.
Responsibilities
- Serve as a GCP Quality team member on Study Execution Teams (SETs) and deliver a cohesive strategic GCP framework across Denali clinical trials.
- Partner with the Zurich Site Lead and cross-functional leaders to drive site growth, operational excellence, and portfolio advancement.
- Monitor, analyze, and report on quality issues; provide strategic, risk-based guidance in line with GCP regulations and industry standards.
- Identify quality and compliance gaps, recommend solutions, and support CAPA development and root cause analysis.
- Participate in the evaluation, selection, and oversight of CROs and clinical vendors to ensure quality standards are met.
- Foster collaboration across internal teams and external partners to maintain systems and processes aligned with regulatory requirements.
- Support inspection readiness activities, including preparation for regulatory agency inspections, audits, and vendor assessments.
- Contribute to the design, implementation, and continuous improvement of GCP Quality Systems, SOPs, and the overall Quality Management System (QMS).
- Perform QA reviews of essential clinical trial documents and assist in the implementation of internal GCP QA processes and tools.
- Represent Clinical Quality Assurance (CQA) in internal initiatives, champion a culture of compliance, ethics, and patient safety, and ensure GCP adherence across clinical programs.
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
