Director, Regulated Diagnostics Lab

About the role

We are seeking an exceptional Laboratory Director to establish and lead a new, FDA-regulated clinical laboratory. This is a rare opportunity to build a laboratory from the ground up - owning every aspect from initial CLIA certification through long-term operations. The successful candidate will hold the CLIA license, direct all laboratory operations, provide technical leadership, and oversee the execution of FDA clinical studies required to support regulatory clearance of a novel home-collection diagnostic test system. During an initial study phase of approximately 18-21 months, the laboratory will function primarily as a controlled study site, conducting pivotal analytical and clinical work in support of FDA clearance. Following clearance, the laboratory will transition to scaled routine clinical operations. The ideal candidate is a proven builder who thrives in both roles: executing rigorous regulated studies while simultaneously designing a laboratory that is built to grow. You Will: Laboratory Establishment & Compliance Obtain CLIA certification for high-complexity testing, including filing the CMS-116, selecting the certification route (Certificate of Compliance or Certificate of Accreditation), and securing the laboratory's CLIA number. Secure applicable state laboratory license(s) and personal director certification of qualification in required operating and patient-service states (e.g., New York CLEP). Design the physical plant and environmental controls: bench layout, sample flow, biosafety, refrigeration/freezer storage with continuous monitoring, and emergency provisions. Select, procure, install, and qualify the analytical platform and any required middleware. Build out the laboratory's full document architecture, including SOPs spanning pre-analytic, analytic, and post-analytic processes, and support development of the Quality Management System and document control. Select and configure the LIS/specimen management system, result-reporting pathways, and data-integrity controls required for a regulated study environment (ALCOA+; 21 CFR Part 11 where applicable). Hire, train, and competency-assess laboratory technologists; establish the CLIA-required competency assessment program. Laboratory Leadership Serve as the CLIA Laboratory Director and license holder, with full accountability under 42 CFR 493.1445. Concurrently serve as Technical Supervisor and, as needed, General Supervisor and Clinical Consultant for the laboratory's full scope of testing. Directly supervise laboratory technologists performing assay testing and specimen accessioning during the initial study phase; plan and support staffing expansion as operations scale. Establish and maintain ongoing competency assessment, QC/QA programs, CAPA, internal audits, proficiency testing enrollment, and accreditation readiness. FDA Clinical Studies Partner with Regulatory, Quality, and Clinical stakeholders to design analytical and clinical studies supporting FDA clearance; own all laboratory-facing portions of study protocols. Lead method validation and verification of the core assay: accuracy, precision, reportable range, analytical sensitivity/specificity, interference testing, and carryover per applicable CLSI guidance. Own the integrity of the pivotal method-comparison study from the bench: ensure specimens are collected, accessioned, aliquoted, labeled, stored, and cataloged correctly, with full chain of custody. Ensure the comparator methodology is appropriate and defensible, including relevant certification and traceability requirements, and that comparator processing meets FDA-recognized standards. Oversee specimen stability and transport condition studies across the end-to-end home-collection-to-laboratory workflow. Maintain the laboratory's contribution to the Test System Design History File and design controls; ensure processes are inspection-ready throughout the study period. Serve as the laboratory's point of contact and subject matter authority in FDA interactions and inspections. Long-Term Operations Transition t

Benefits

Additional Information

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol "HIMS." To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company's outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals .

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