Biosample Operations Lead, Clinical Lab Strategy Oversight

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

Benefits offered by this job

401k

Healthcare coverage

ESPP

Comprehensive benefits

Job summary

Denali Therapeutics Inc. is seeking a Biosample Operations Leader to safeguard biospecimen data across Phase I–IV trials. You will translate biospecimen strategy into compliant execution with specialty lab vendors, ensuring data integrity and on-time development decisions.

You will lead audits, drive process improvements, and align testing strategies with cross-functional teams while overseeing budget and vendor performance in a fast-paced biotech environment.

Qualifications

• Bachelor’s degree in biology, biochemistry, analytical chemistry, medical technology, or related field.
• Typically 9+ years in Clinical Operations, Biosample Operations, Translational Sciences, or Bioanalytical Sciences.
• Typically 5+ years managing direct reports.
• Experience overseeing biosample or clinical lab vendors and driving corrective actions.
• Familiarity with FDA, ICH/GCP, GDPR, IVDR, and GCLP regulations.

Responsibilities

• Lead vendor identification, qualification, and oversight of bioanalytical and clinical diagnostic labs for Phase I–IV trials.
• Direct biosample strategy and standards to improve efficiency, scalability, and vendor performance.
• Partner with Quality and Regulatory to ensure lab processes meet GCLP, GCP, and applicable IVD regulations.
• Align biomarker, PK, and immunogenicity testing with cross-functional teams.
• Manage audits, inspections, and CAPA to maintain inspection readiness.
• Serve as Biosample Operations Program Lead across assigned development programs.
• Communicate laboratory status, risks, and escalations to study teams and partners.
• Oversee contracts and budgets for specialty laboratory vendors.
• Supervise Biosample Operations leads and set performance goals.

Skills

Biosample Ops

Vendor oversight

Regulatory compliance

Cross-functional collab

Budget management

Education

Bachelor’s degree in Biology/Biochemistry/Analytical Chemistry/Medical Technology

Tools

FDA/ICH-GCP knowledge

GCLP standards

Job description

Denali Therapeutics Inc. is seeking a Biosample Operations Leader to safeguard biospecimen data across Phase I–IV trials. You will translate biospecimen strategy into compliant execution with specialty lab vendors, ensuring data integrity and on-time development decisions.

You will lead audits, drive process improvements, and align testing strategies with cross-functional teams while overseeing budget and vendor performance in a fast-paced biotech environment.