Associate Director, Biosample Operations & Lab Strategy

Denali Therapeutics Inc.; South San Francisco (CA); On-site; USD 171,000 - 223,000; Full time

Job summary

Denali Therapeutics Inc. is seeking an Associate Director of Biosample Operations in South San Francisco to safeguard biosample data quality for Phase I–IV trials. Lead vendor oversight, guide biosample strategy, and partner with QA/Regulatory to ensure GCLP and GCP compliance across clinical programs.

You will manage lab audits, CAPA resolution, and cross-functional communication, while directing biosample operations leads and overseeing budgets with external vendors.

Qualifications

• Bachelor’s degree in Biology or related field required.
• Experience overseeing bioanalytical/lab vendors and clinical operations preferred.
• Strong knowledge of FDA/ICH/GCP and GCLP regulations.

Responsibilities

• Lead vendor identification, qualification, and oversight of bioanalytical labs.
• Direct biosample strategies, improving efficiency and vendor performance.
• Ensure GCLP/GCP compliance and manage audits/inspections.

Skills

Vendor management

Biosample operations

Education

Bachelor’s degree in Biology

Job description

Denali Therapeutics Inc. is seeking an Associate Director of Biosample Operations in South San Francisco to safeguard biosample data quality for Phase I–IV trials. Lead vendor oversight, guide biosample strategy, and partner with QA/Regulatory to ensure GCLP and GCP compliance across clinical programs.

You will manage lab audits, CAPA resolution, and cross-functional communication, while directing biosample operations leads and overseeing budgets with external vendors.