HH
Senior Scientist, Regulatory & Clinical Operations
Hims and HersSouth Plainfield, NJ · full time · Senior
$130,000 – $150,000
Listed on Hims and Hers’s own careers site. You apply with them directly — we never stand between you and the employer.
What this role is
A scientific role managing clinical studies and laboratory assay execution for a telehealth company's FDA-regulated diagnostic testing programs. This suits someone with deep bench expertise who enjoys moving between hands-on laboratory work and the operational side of bringing studies to completion.
Our summary, not Hims and Hers’s wording. The full posting is on their site.
Skills this role names
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What they ask for
Required
- PhD in Clinical Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology or related field with 4+ years experience; OR Master's degree with 7+ years; OR Bachelor's degree with 10+ years in diagnostic or clinical laboratory
- Experience coordinating clinical or regulated studies with a CRO
- Experience supporting FDA-regulated studies (510(k), De Novo, or PMA pathways)
- Hands-on assay development and execution experience
- Experience with venous and/or capillary blood specimens and biological matrices
- Ability to reconcile clinical sample data across tracking and laboratory systems
- Project management and organizational skills for study timelines and cross-functional coordination
- Basic statistical analysis capability
- Working knowledge of Quality Management Systems and design control processes
- Cross-functional communication skills with ability to present complex data to technical and non-technical audiences
- Ability to work independently and drive study execution
Nice to have
- Experience validating capillary microsampling devices (Tasso, TAP) for regulated studies
- Experience with at-home or point-of-care diagnostic testing programs
- Experience with dried blood spot (DBS) workflows and stability characterization
- Statistical analysis software experience (JMP, Analyse-It)
- Clinical data management and monitoring process experience
- Familiarity with patient safety monitoring and adverse event reporting for human subjects research
- Familiarity with biomarkers in metabolic health, longevity, and consumer wellness testing
- Hands-on experience with AI/ML tools (Python, Copilot Studio) for process improvement