Director, Regulated Diagnostics Lab

hims & hers
United States
Workplace: OnsiteFull timeUSD 210,000 - 240,000 annuallyFunction: Laboratory & Clinical OperationsEducation: phdSkills: ["Leadership","Regulatory","Communication","Problem-solving"]

Lead the establishment and ongoing operations of an FDA-regulated clinical laboratory from initial CLIA certification through scaled routine operations. Oversee compliance, study execution for FDA clearance, and long-term laboratory strategy in a fast-moving, regulated environment.

Loading

Loading job details...

Preparing the role view and application actions.

FursaFursa
hims & hers
hims & hers
1 month ago

Director, Regulated Diagnostics Lab

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 16 hours agoStatus: Live

Job Summary

Lead the establishment and ongoing operations of an FDA-regulated clinical laboratory from initial CLIA certification through scaled routine operations. Oversee compliance, study execution for FDA clearance, and long-term laboratory strategy in a fast-moving, regulated environment.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Laboratory & Clinical Operations
Seniority: Sr. Manager level

Key Responsibilities

  • •Establish and maintain CLIA high-complexity laboratory operations, including certification, licensing, facility design, and systems qualification.
  • •Serve as Laboratory Director with accountability under 42 CFR 493.1445 and, as needed, Technical Supervisor and Clinical Consultant for the full testing scope.
  • •Lead FDA clinical studies by designing analytical/clinical study protocols, validating core assays, and ensuring chain-of-custody and regulatory compliance.
  • •Oversee long-term operations: define throughput, staffing, automation, turnaround times, and quality metrics as the lab scales.
  • •Ensure ongoing compliance obligations (proficiency testing, CAPA, QC/QA, internal audits, accreditation readiness) and act as point of contact for FDA inspections.

Pay and Benefits

Salary: USD 210,000 - 240,000 annually
Equity and Bonus:Equity
Perks:Equity401kPaid LeaveHealth InsuranceParental LeaveEsppOffsite Retreats

Key Requirements

  • •Doctoral degree (MD, DO, or PhD) in a chemical, physical, biological, or clinical laboratory science
  • •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, CLSI standards, FDA IVD requirements)
  • •Ability to make a laboratory inspection-ready and defend its processes and data to regulators
Experience:HealthcareLaboratoryBiotech
Education:PhD / Doctorate
Skills:LeadershipRegulatoryCommunicationProblem-solving
Licenses:CLIA licenseState laboratory licenses
Tech Stack:LISALCOA+21 CFR Part 11CAPAQC/QA

Company Brief

hims & hers
A telehealth and consumer wellness platform offering personalized care and products across sexual health, hair, mental health, dermatology, weight loss and primary care via digital consultations, prescriptions, and fulfillment.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Francisco, United States
Founded: 2017
Glassdoor
Glassdoor: 2.9
WebsiteLinkedInGlassdoor