Denali Therapeutics brings the power of biotherapeutics to the whole body, including the brain. We discover, develop and deliver medicines for people living with serious diseases. Backed by GV.
About the role
Lead vendor identification, qualification, and oversight of bioanalytical and clinical diagnostic laboratories supporting Phase I–IV clinical trials, ensuring quality, compliance, and timeline adherence. Direct biosample operational strategy and standards, driving improvements in efficiency, scalability, and vendor performance.
What they're looking for
- Bachelor’s degree in Biology, Biochemistry, Analytical Chemistry, Medical Technology, or a related field
- Typically 9+ years of experience in Clinical Operations, Biosample Operations, Translational Sciences, or Bioanalytical Sciences
- Typically 5+ years of experience managing direct reports
- Demonstrated experience overseeing bioanalytical or clinical diagnostic laboratory vendors, including issue identification and resolution
- Working knowledge of FDA, ICH/GCP, GDPR, IVDR, and GCLP regulations
More about this role
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.
This role safeguards the quality and continuity of biosample data that underpins clinical development and regulatory submissions across Phase I–IV trials. It exists to translate biospecimen strategy into consistent, compliant execution across specialty laboratory vendors, protecting both data integrity and program timelines. Leading vendor oversight and cross-functional alignment, this position ensures inspection readiness and enables confident, data-driven development decisions across the clinical portfolio.
Lead...
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