Senior Regulatory & Clinical Scientist – FDA-Regulated Studies

Socket.dev; SOUTH PLAINFIELD (NJ); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO

Health benefits

401k with employer matching

ESPP

Offsite team retreats

Job summary

Hims & Hers is seeking a Senior Scientist, Regulatory & Clinical Operations to lead coordination of FDA-regulated studies in our Central New Jersey on-site lab. The role sits at the intersection of bench science and clinical study execution, reporting to the Director of R&D.

You will own end-to-end study execution with a CRO partner and ensure GCP compliance. The ideal candidate thrives in a fast-paced environment, translates regulatory rigor into practical decisions, and can operate

Qualifications

• PhD or equivalent with years of bench/clinical study experience.

Responsibilities

• Coordinate FDA-regulated studies with CRO partners.

Skills

Clinical study coordination

FDA-regulated studies

Project management

Cross-functional collaboration

Analytical chemistry

Assay development

Regulatory understanding

Education

PhD in Clinical Chemistry

Master’s degree in related field

Bachelor’s degree with extensive bench experience

Tools

Python

Copilot Studio

JMP

Analyse-It

LC-MS/MS

Job description

Hims & Hers is seeking a Senior Scientist, Regulatory & Clinical Operations to lead coordination of FDA-regulated studies in our Central New Jersey on-site lab. The role sits at the intersection of bench science and clinical study execution, reporting to the Director of R&D.

You will own end-to-end study execution with a CRO partner and ensure GCP compliance. The ideal candidate thrives in a fast-paced environment, translates regulatory rigor into practical decisions, and can operate