Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
The Associate Director, Clinical Quality, reporting to the Director of Clinical Quality Assurance (CQA), will create, implement, and oversee a strategic GCP framework to support Denali’s clinical Study Execution Teams. This position will be able to provide a strong GCP perspective in study team discussions, provide ad hoc guidance for study team queries, and proactively identify and address study related compliance risks.
The successful candidate must be able to work in a spirit of collaboration and service, while also operating with a high level of independent judgment and leadership. Denali is seeking candidates with a can-do attitude who work with the highest integrity, fostering an environment of compliance and continuous improvement.
Serve as GCP Quality team member on the Study Execution Teams and define a risk-based model for study support. Track and prepare updates on quality issues. Provide expert CQA advice and risk-based strategic guidance based on analysis and interpretation of GCP regulations
Responsible for identifying quality and compliance issues and actively finding solutions
Manage QA reviews of essential clinical trial documents (manual, study plans) for compliance with regulations
Advises and coaches study teams to ensure compliance with internal and external policies, laws, and regulations
Assist in the development of CAPAs with an emphasis on root cause analysis
Participate in the evaluation and selection of CROs and other clinical vendors
Promote collaboration internally and with external partners to ensure systems and processes comply with applicable standards, regulations, and guidelines
Support the preparation and conduct of clinical inspections by Regulatory Agencies and partner audits as needed
Must operate independently and highly autonomously.
Assist in developing and implementing internal processes and systems related to GCP QA
Make recommendations for improvements to the QMS to bolster compliance across all studies
8+ years working in GCP QA
Working knowledge of ICH E6(R2) 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 required
Vendor assessment and qualification experience desired
People management experience strongly preferred
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, able to multi-task, and thrives under pressure
Able to work across multiple projects and prioritize tasks as required
Degree in health/science related discipline preferred