Hims & Hers
Senior Scientist, Regulatory & Clinical Operations
$130K–$150K
South Plainfield, New Jersey · On-site · Senior · Full-time · Posted Aug 11, 2026
- Experience
- PhD: 4+ years; Master’s: 7+ years; Bachelor’s: 10+ years of relevant bench experience.
- Education
- PhD in Clinical Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology, or related field; OR Master’s degree; OR Bachelor’s degree.
About the job
Coordinates FDA-regulated clinical studies from kickoff through completion while performing assay testing and supporting regulatory compliance in an on-site laboratory role in Central New Jersey.
What you'll do
- Lead CRO coordination, study execution, documentation, timelines, and protocol adherence; support IRB and informed-consent activities.
- Perform assays and validation testing, troubleshoot study issues, and assess venous and capillary specimens.
- Partner with Quality on regulatory compliance, data integrity, audits, and technical reports; serve as interim lab manager as needed.
What they ask for
- Experience coordinating clinical or regulated studies and supporting FDA-regulated studies.
- Hands-on assay development and execution experience, including blood-based specimens and biological matrices.
- Working knowledge of QMS and design control; ability to perform basic statistical analysis and coordinate study timelines.
- PhD with 4+ years, Master’s degree with 7+ years, or Bachelor’s degree with 10+ years of relevant bench experience in a diagnostic or clinical laboratory setting.
Nice to have
- Experience validating capillary microsampling devices or with at-home/point-of-care testing, DBS workflows, or clinical data management.
- Familiarity with statistical software (e.g., JMP, Analyse-It), patient safety reporting, or AI/ML tools (e.g., Python, Copilot Studio).
Pay
$130K – $150K USD base salary
Tools
Roche Cobas, SCIEX 4500MD, LC-MS/MS, CLSI, FDA QSR, ISO 13485, JMP, Python
AI focus
Preferred familiarity with AI/ML tools such as Python or Copilot Studio for process improvement or data workflows.
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