Director, Regulated Diagnostics Lab
Job Location:
South Plainfield, NJ - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
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 were 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 and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit the Role: We are seeking an exceptional Laboratory Director to establish and lead a 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. 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. 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 laboratorys 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 lab 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 laboratorys 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 laboratorys 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. Long-Term Operations 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. 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. 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 blood 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. 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 We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics wellness and a strong sense of belonging. If youre excited about this role we encourage you to applyeven if youre not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment including applicants with arrest or conviction records in accordance with the San Francisco Fair Chance Ordinance the Los Angeles County Fair Chance Ordinance the California Fair Chance Act and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability please contact us at and describe the needed accommodation. Your privacy is important to us and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status including disability. Please do not send resumes to this email address. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement. Required Experience: DirectorYou Will:
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Preferred Qualifications
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About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
