Director, Regulated Diagnostics Lab

Responsibilities

• Establish and lead a new, FDA-regulated clinical laboratory from the ground up, including obtaining CLIA certification and state licenses.
• Serve as the CLIA Laboratory Director, Technical Supervisor, and Clinical Consultant with full accountability for high-complexity testing.
• Design the physical laboratory plant, environmental controls, sample flow, and document architecture (SOPs and QMS).
• Partner with Regulatory and Quality teams to design and execute analytical and clinical studies to support FDA clearance.
• Lead method validation and verification for core assays, ensuring compliance with CLSI guidance and FDA requirements.
• Oversee the transition from a controlled study site to a scaled, routine clinical operations model.
• Hire, train, and manage laboratory technologists and establish competency assessment programs.

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.
• 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.
• Working command of CLIA (42 CFR 493), CLSI standards, and FDA IVD requirements.
• Proven ability to maintain inspection-ready processes and defend data to regulatory authorities.

Preferred Qualifications

• Licensed to serve as a laboratory director in New York and New Jersey.
• Experience supporting FDA 510(k) or PMA submissions, specifically generating data for IVD or test systems.
• Domain expertise in HbA1c testing methodologies and NGSP certification.
• Familiarity with capillary and self-collected specimen types.

Benefits

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

About the Company

Hims & Hers is a leading health and wellness platform on a mission to help the world feel great through better health. We are redefining healthcare by delivering affordable, accessible, and personalized care from diagnosis to treatment to delivery.