Associate Director, Clinical Quality

About the role

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.

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.

Qualifications/Skills

• Bachelor's Degree and 7+ years experience, with 6+ working in GCP QA.
• Early phase study support experience desirable.
• 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.

Pay

$193,638.00 to $224,270.00. 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.