Senior Manager, Clinical Laboratory Operations

Zenas BioPharma; Waltham (MA); On-site; USD 135,000 - 168,000; Full time

Job summary

Zenas BioPharma is seeking a Senior Manager, Clinical Laboratory Operations to lead end-to-end laboratory sample management across clinical programs in the US. You will coordinate with Translational Sciences, Clinical Operations, Data Management, QA, and CROs to ensure compliant, timely, high-quality data generation.

The role requires strong vendor oversight, lab operations experience, and the ability to drive process improvements in a growing biotech environment.

Qualifications

• Bachelor’s degree in life sciences, clinical research, laboratory sciences, or related discipline required; advanced degree preferred.
• 6+ years of relevant experience in clinical sample management.
• Strong working knowledge of clinical sample collection, processing, shipping, inventory tracking, testing workflows, data transfers, sample reconciliation, and long‑term sample storage requirements.
• Demonstrated experience managing external vendors, including CROs, central laboratories, specialty biomarker laboratories, sample storage vendors, and other clinical trial service providers.
• Experience supporting global clinical trials and working cross‑functionally
• Familiarity with GCP, ICH guidelines, informed consent requirements, sample chain of custody, data privacy considerations, and clinical trial inspection readiness expectations.
• Proven ability to manage multiple studies, vendors, priorities, budgets, and timelines in a fast‑paced, matrixed environment with strong attention to detail and quality.
• Excellent communication, collaboration, problem‑solving, and organizational skills, with the ability to influence internal and external stakeholders and drive issues to resolution.
• Comfort operating in a growing, entrepreneurial organization and contributing to process development, continuous improvement, and scalable biomarker operations infrastructure.

Responsibilities

• Plan and manage biomarker, bioanalytical and central lab sample logistics across clinical trials, including sample kits and supplies, collection, processing, shipment, testing, reconciliation, storage, inventory tracking, chain of custody, use tracking, and final disposition.
• Serve as the laboratory operations lead on assigned study teams, providing input into clinical protocols, informed consent forms, laboratory manuals, sample collection schedules, sample management plans, collection guidance, inventory tracking processes, data delivery timelines, and related study documents.
• Oversee and manage external laboratories, CROs, central labs, specialty testing vendors, sample storage vendors, and other clinical trial service providers, including identification, qualification, onboarding, performance management, issue resolution, review of scopes of work, budgets, contracts, laboratory capabilities, operational risks, and adherence to contractual scope, budget, and timelines.
• Coordinate data transfer specifications, sample reconciliation outputs, testing status updates, final deliverables, and delivery of quality data in collaboration with Translational Sciences, Data Management, Clinical Operations, and vendors.
• Support inspection readiness, quality activities, process improvements, and gap assessments by ensuring lab‑related documentation is complete, current, and filed appropriately, while proactively identifying, escalating, and resolving operational risks, bottlenecks, and quality issues related to lab sample handling, testing, and reporting.
• Drive continuous improvement of lab sample operations processes, templates, vendor oversight practices, sample management systems, and scalable biomarker operations infrastructure across the clinical portfolio.

Education

Bachelor’s degree in life sciences

Job description

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best‑in‑class, highly selective CNS‑penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include ZB021, a clinical-stage, potentially best‑in‑class, oral, IL‑17AA/AF inhibitor; ZB022, a preclinical, potentially best‑in‑class, oral, brain‑penetrant, TYK2 inhibitor; and ZB014, a preclinical half‑life extended anti‑CD‑19 and FcγRIIb monoclonal antibody.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast‑paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!

Position Summary

The Senior Manager, Clinical Laboratory Operations will be responsible for leading the operational execution of laboratory sample collection, tracking, testing, reconciliation, data transfer, and final sample disposition across Zenas’ clinical development programs. This role will partner closely with Translational Sciences, Clinical Development, Clinical Operations, Data Management, Quality Assurance, Procurement, Legal, Finance, CROs, central laboratories, and specialty biomarker vendors to ensure all laboratory activities are delivered with quality, compliance, efficiency, and clear communication. The successful candidate will bring strong clinical sample management expertise, vendor oversight experience, and operational leadership to support high‑quality laboratory data generation that informs clinical development strategy.

Key Responsibilities

• Plan and manage biomarker, bioanalytical and central lab sample logistics across clinical trials, including sample kits and supplies, collection, processing, shipment, testing, reconciliation, storage, inventory tracking, chain of custody, use tracking, and final disposition.


• Serve as the laboratory operations lead on assigned study teams, providing input into clinical protocols, informed consent forms, laboratory manuals, sample collection schedules, sample management plans, collection guidance, inventory tracking processes, data delivery timelines, and related study documents.


• Oversee and manage external laboratories, CROs, central labs, specialty testing vendors, sample storage vendors, and other clinical trial service providers, including identification, qualification, onboarding, performance management, issue resolution, review of scopes of work, budgets, contracts, laboratory capabilities, operational risks, and adherence to contractual scope, budget, and timelines.


• Coordinate data transfer specifications, sample reconciliation outputs, testing status updates, final deliverables, and delivery of quality data in collaboration with Translational Sciences, Data Management, Clinical Operations, and vendors.


• Support inspection readiness, quality activities, process improvements, and gap assessments by ensuring lab‑related documentation is complete, current, and filed appropriately, while proactively identifying, escalating, and resolving operational risks, bottlenecks, and quality issues related to lab sample handling, testing, and reporting.


• Drive continuous improvement of lab sample operations processes, templates, vendor oversight practices, sample management systems, and scalable biomarker operations infrastructure across the clinical portfolio.

Qualifications

• Bachelor’s degree in life sciences, clinical research, laboratory sciences, or a related discipline required; advanced degree preferred.


• 6+ years of relevant experience in clinical sample management.


• Strong working knowledge of clinical sample collection, processing, shipping, inventory tracking, testing workflows, data transfers, sample reconciliation, and long‑term sample storage requirements.


• Demonstrated experience managing external vendors, including CROs, central laboratories, specialty biomarker laboratories, sample storage vendors, and other clinical trial service providers.


• Experience supporting global clinical trials and working cross‑functionally


• Familiarity with GCP, ICH guidelines, informed consent requirements, sample chain of custody, data privacy considerations, and clinical trial inspection readiness expectations.


• Proven ability to manage multiple studies, vendors, priorities, budgets, and timelines in a fast‑paced, matrixed environment with strong attention to detail and quality.


• Excellent communication, collaboration, problem‑solving, and organizational skills, with the ability to influence internal and external stakeholders and drive issues to resolution.


• Comfort operating in a growing, entrepreneurial organization and contributing to process development, continuous improvement, and scalable biomarker operations infrastructure.

The position is eligible for a competitive compensation and benefits package.

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $134,500 to $168,228. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.

Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.