Director, Regulated Diagnostics Lab

Hims & Hers • South Plainfield, NJ

10d • $210,000 - $240,000 • Remote

About The Position

Hims & Hers is 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.

Requirements

• Doctoral degree (MD, DO, or PhD in a chemical, physical, biological, or clinical laboratory science) qualifying you to serve as a CLIA high-complexity Laboratory Director under 42 CFR 493.1443, including applicable board certification.
• Demonstrated experience serving as a CLIA Laboratory Director and/or Technical Supervisor for high-complexity testing.
• Hands-on expertise in clinical chemistry method validation and quality control (calibration, proficiency testing, etc.).
• Working command of the regulatory frameworks governing clinical laboratory operations: CLIA (42 CFR 493), relevant CLSI standards, and FDA IVD requirements, including familiarity with design controls and the Quality Management System Regulation (21 CFR 820 / QMSR).
• Ability to make a laboratory inspection-ready and to defend its processes and data to regulatory authorities.

Nice To Haves

• Licensed to serve as a laboratory director in New York and New Jersey States and other applicable states.
• Experience supporting FDA 510(k) or PMA submissions, particularly in generating analytical and clinical study data for IVD or test systems.
• Domain depth in HbA1c testing: assay methodologies (enzymatic, immunoassay, HPLC/capillary electrophoresis), NGSP certification, and IFCC traceability.
• Familiarity with capillary and self-collected specimen types and the pre-analytic considerations they introduce.
• Comfort operating in a fast-moving, commercially driven environment alongside cross-functional partners in regulatory, quality, clinical, product, and operations.

Responsibilities

• 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.
• 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.
• 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.
• Transition the laboratory from a study site to a scaled, operational clinical laboratory delivering cleared diagnostic testing.
• Define and document the long-term operating model: throughput, staffing, automation, turnaround-time targets, and quality metrics.
• Establish the roadmap for extending the laboratory platform to additional analytes and tests, along with the associated regulatory and operational framework.
• Maintain all ongoing compliance obligations: proficiency testing, competency assessment, QC/QA programs, CAPA, internal audits, and accreditation readiness.

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree