Associate Director, Biosample Operations

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

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.

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, 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.

Qualifications/Skills Required:

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. Preferred: Experience developing tools or systems that improve biosample operational workflows.

Salary Range:

$171,000.00 to $223,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Life at Denali

Life at Denali is a living reflection of our values: trust, unity, grit and growth. These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.