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About the Role

This role safeguards the quality and continuity of biosample data that underpins clinical development and regulatory submissions across Phase I–IV trials. It translates 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.

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.

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

Skills

GCLP
GCP
IVD regulations
Biomarker testing
PK testing
Immunogenicity testing
FDA regulations
ICH/GCP regulations
GDPR regulations
IVDR regulations

Location

Remote

Work Type

Full-time

Experience Level

9+ years of experience in Clinical Operations, Biosample Operations, Translational Sciences, or Bioanalytical Sciences
5+ years of experience managing direct reports

Education Level

Bachelor’s degree in Biology, Biochemistry, Analytical Chemistry, Medical Technology, or a related field.

Salary/Compensations

$171,000.00 to $223,000.00

Benefits

401k
Healthcare coverage
ESPP

About the Company

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.
Learn more at https://www.denalitherapeutics.com/careers

Equal Opportunity

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.