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.
