# Senior Scientist, Regulatory & Clinical Operations

Hiring organization: [Hims and Hers](https://career.thegoodapps.co/organizations/hims-and-hers)

Canonical page: https://career.thegoodapps.co/jobs/475bbb44-928b-4cc0-a4d5-c3d28d1d09cb

Listed on Hims and Hers's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Senior
- Location: South Plainfield, NJ
- Salary: 130000 – 150000 USD per year

## Summary

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._

## Skills named

Analytical Chemistry, ISO 13485, Python, Quality Management Systems, Statistical Analysis

## 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

Apply on Hims and Hers's site: https://jobs.ashbyhq.com/hims-and-hers/cc555f05-d531-4101-a086-649ef72fed4a/application