Senior Manager, Clinical Laboratory Operations
Zenas BioPharma
August 12, 2026
Remote friendly (Waltham, MA)
United States
Operations
Position Summary
Senior Manager, Clinical Laboratory Operations will lead the operational execution of laboratory sample collection, tracking, testing, reconciliation, data transfer, and final sample disposition across Zenas’ clinical development programs. Partner with Translational Sciences, Clinical Development, Clinical Operations, Data Management, Quality Assurance, Procurement, Legal, Finance, CROs, central laboratories, and specialty biomarker vendors to ensure high-quality, compliant, efficient lab data generation.
Key Responsibilities
- Plan and manage biomarker, bioanalytical and central lab sample logistics (kits/supplies, collection, processing, shipment, testing, reconciliation, storage, inventory tracking, chain of custody, use tracking, final disposition).
- Serve as laboratory operations lead for assigned study teams; contribute to protocols, informed consent forms, laboratory manuals, sample collection schedules, sample management plans, collection guidance, inventory tracking processes, and data delivery timelines.
- Oversee/manage external labs, CROs, central labs, specialty testing vendors, and sample storage vendors (qualification, onboarding, performance management, issue resolution, SOWs, budgets, contracts, capabilities, risks, and adherence to scope/timelines).
- Coordinate data transfer specifications and sample reconciliation outputs; manage testing status updates and final deliverables.
- Support inspection readiness and quality improvements by maintaining complete/current documentation and identifying/escalating/resolving lab handling/testing/reporting risks and bottlenecks.
- Drive continuous improvement of lab sample operations processes, templates, vendor oversight practices, sample management systems, and scalable biomarker operations infrastructure.
Qualifications
- Bachelor’s degree in life sciences, clinical research, laboratory sciences, or related; advanced degree preferred.
- 6+ years of clinical sample management experience.
- Knowledge of sample collection/processing/shipping, inventory tracking, testing workflows, data transfers, sample reconciliation, and long-term storage.
- Experience managing CROs/central labs/specialty biomarker labs and sample storage vendors.
- Experience with global clinical trials and cross-functional work.
- Familiarity with GCP, ICH, informed consent requirements, chain of custody, data privacy, and inspection readiness.
- Ability to manage multiple studies/vendors/priorities/budgets/timelines in a matrixed, fast-paced environment.
- Strong communication, collaboration, problem-solving, and organizational skills; ability to influence stakeholders and drive resolution.
Benefits
- Competitive compensation and benefits package; base salary range: $134,500–$168,228; total rewards include annual performance bonus, equity, full benefits, and other incentives.
Senior Manager, Clinical Laboratory Operations will lead the operational execution of laboratory sample collection, tracking, testing, reconciliation, data transfer, and final sample disposition across Zenas’ clinical development programs. Partner with Translational Sciences, Clinical Development, Clinical Operations, Data Management, Quality Assurance, Procurement, Legal, Finance, CROs, central laboratories, and specialty biomarker vendors to ensure high-quality, compliant, efficient lab data generation.
Key Responsibilities
- Plan and manage biomarker, bioanalytical and central lab sample logistics (kits/supplies, collection, processing, shipment, testing, reconciliation, storage, inventory tracking, chain of custody, use tracking, final disposition).
- Serve as laboratory operations lead for assigned study teams; contribute to protocols, informed consent forms, laboratory manuals, sample collection schedules, sample management plans, collection guidance, inventory tracking processes, and data delivery timelines.
- Oversee/manage external labs, CROs, central labs, specialty testing vendors, and sample storage vendors (qualification, onboarding, performance management, issue resolution, SOWs, budgets, contracts, capabilities, risks, and adherence to scope/timelines).
- Coordinate data transfer specifications and sample reconciliation outputs; manage testing status updates and final deliverables.
- Support inspection readiness and quality improvements by maintaining complete/current documentation and identifying/escalating/resolving lab handling/testing/reporting risks and bottlenecks.
- Drive continuous improvement of lab sample operations processes, templates, vendor oversight practices, sample management systems, and scalable biomarker operations infrastructure.
Qualifications
- Bachelor’s degree in life sciences, clinical research, laboratory sciences, or related; advanced degree preferred.
- 6+ years of clinical sample management experience.
- Knowledge of sample collection/processing/shipping, inventory tracking, testing workflows, data transfers, sample reconciliation, and long-term storage.
- Experience managing CROs/central labs/specialty biomarker labs and sample storage vendors.
- Experience with global clinical trials and cross-functional work.
- Familiarity with GCP, ICH, informed consent requirements, chain of custody, data privacy, and inspection readiness.
- Ability to manage multiple studies/vendors/priorities/budgets/timelines in a matrixed, fast-paced environment.
- Strong communication, collaboration, problem-solving, and organizational skills; ability to influence stakeholders and drive resolution.
Benefits
- Competitive compensation and benefits package; base salary range: $134,500–$168,228; total rewards include annual performance bonus, equity, full benefits, and other incentives.