Senior Manager, Clinical Laboratory Operations

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 trans