Regulatory & Clinical Scientist - Lead FDA Studies

hims & hers; SOUTH PLAINFIELD (NJ); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO

Comprehensive health benefits

ESPP

401k benefits

Offsite team retreats

Job summary

Hims & Hers is seeking a Senior Scientist, Regulatory & Clinical Operations to join our Central New Jersey laboratory. This role reports to the Director of R&D and leads the execution of FDA-regulated studies in collaboration with a contracted CRO.

The ideal candidate blends bench science with clinical study execution, translating regulatory rigor into practical decisions. On-site lab work in Central New Jersey is essential.

Qualifications

• Experience coordinating regulated studies, ideally with CRO
• Experience with FDA-regulated studies (510(k)/De Novo/PMAs)
• Hands-on assay development and execution lifecycle

Responsibilities

• Coordinate FDA-regulated studies with CROs and study sites
• Own day-to-day study execution and protocol adherence per GCP
• Manage sample logistics and data collection
• Review study protocols ensuring regulatory compliance
• Prepare regulatory submissions and reports
• Lead QA/Audit readiness activities for the study
• Oversee day-to-day lab operations as interim manager
• Collaborate with Quality and Clinical Laboratory Operations

Skills

Regulatory coordination

GCP knowledge

Project management

Data interpretation

Education

PhD in Clinical Chemistry/related field

MS in related field

BS with 10+ years bench experience

Tools

Roche Cobas

LC-MS/MS (SCIEX 4500MD)

Job description

Hims & Hers is seeking a Senior Scientist, Regulatory & Clinical Operations to join our Central New Jersey laboratory. This role reports to the Director of R&D and leads the execution of FDA-regulated studies in collaboration with a contracted CRO.

The ideal candidate blends bench science with clinical study execution, translating regulatory rigor into practical decisions. On-site lab work in Central New Jersey is essential.