Associate Director, Biosample Operations
Denali Therapeutics
August 06, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Key Accountabilities/Core Job Responsibilities:
- 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, improving efficiency, scalability, and vendor performance.
- Partner with Quality and Regulatory teams to ensure laboratory processes and documentation comply with GCLP, GCP, and applicable IVD regulations.
- Align biomarker, PK, and immunogenicity testing strategies with cross-functional development teams.
- Manage laboratory audits, inspections, and CAPA resolution to maintain continuous inspection readiness.
- Serve as Biosample Operations Program Lead, directing biospecimen strategy across assigned clinical development programs.
- Communicate laboratory operational status, risks, and escalations to study teams, leadership, and external partners.
- Oversee contract and budget performance for specialty laboratory vendors.
- Supervise and develop Biosample Operations clinical study leads (set annual goals; provide performance feedback).
Qualifications/Skills Required:
- Bachelor’s degree in Biology, Biochemistry, Analytical Chemistry, Medical Technology, or related field.
- Typically 9+ years’ experience in Clinical Operations, Biosample Operations, Translational Sciences, or Bioanalytical Sciences.
- Typically 5+ years’ experience managing direct reports.
- Demonstrated experience overseeing bioanalytical/clinical diagnostic laboratory vendors (issue identification and resolution).
- Working knowledge of FDA, ICH/GCP, GDPR, IVDR, and GCLP regulations.
Preferred:
- Experience developing tools/systems that improve biosample operational workflows.
Benefits/Salary:
- Salary range: $171,000.00 to $223,000.00; total rewards include 401k, healthcare coverage, and ESPP.
Application Instructions:
- Learn more at https://www.denalitherapeutics.com/careers
- 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, improving efficiency, scalability, and vendor performance.
- Partner with Quality and Regulatory teams to ensure laboratory processes and documentation comply with GCLP, GCP, and applicable IVD regulations.
- Align biomarker, PK, and immunogenicity testing strategies with cross-functional development teams.
- Manage laboratory audits, inspections, and CAPA resolution to maintain continuous inspection readiness.
- Serve as Biosample Operations Program Lead, directing biospecimen strategy across assigned clinical development programs.
- Communicate laboratory operational status, risks, and escalations to study teams, leadership, and external partners.
- Oversee contract and budget performance for specialty laboratory vendors.
- Supervise and develop Biosample Operations clinical study leads (set annual goals; provide performance feedback).
Qualifications/Skills Required:
- Bachelor’s degree in Biology, Biochemistry, Analytical Chemistry, Medical Technology, or related field.
- Typically 9+ years’ experience in Clinical Operations, Biosample Operations, Translational Sciences, or Bioanalytical Sciences.
- Typically 5+ years’ experience managing direct reports.
- Demonstrated experience overseeing bioanalytical/clinical diagnostic laboratory vendors (issue identification and resolution).
- Working knowledge of FDA, ICH/GCP, GDPR, IVDR, and GCLP regulations.
Preferred:
- Experience developing tools/systems that improve biosample operational workflows.
Benefits/Salary:
- Salary range: $171,000.00 to $223,000.00; total rewards include 401k, healthcare coverage, and ESPP.
Application Instructions:
- Learn more at https://www.denalitherapeutics.com/careers