Associate Director, Biosample Operations

Denali Therapeutics•South San Francisco, CA

2d•$171,000 - $223,000

About The Position

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.

Requirements

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.

Nice To Haves

Experience developing tools or systems that improve biosample operational workflows.

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, driving improvements in 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, functional leadership, and external partners.
Oversee contract and budget performance for specialty laboratory vendors.
Supervise and develop Biosample Operations clinical study leads, setting annual goals and providing ongoing performance feedback.