Clinical Studies Scientist & Regulatory Operations

Hims; SOUTH PLAINFIELD (NJ); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO

Comprehensive health benefits

401k with company matching

Job summary

Hims & Hers seeks a Senior Scientist, Regulatory & Clinical Operations to own execution of FDA-regulated studies within our Central New Jersey laboratory. You will coordinate with CROs and drive studies from kickoff to completion, ensuring regulatory compliance and scientific rigor.

The ideal candidate combines bench science expertise with clinical study execution and thrives in a fast-paced environment, reporting to the Director of R&D for centralized leadership and regulatory oversight.

Qualifications

• PhD or equivalent with years of bench experience in clinical lab settings.
• Experience coordinating regulated studies with CRO partners.
• Experience supporting FDA-regulated studies (510(k)/De Novo/PMA).
• Hands-on assay development and execution lifecycle.
• Experience with venous/capillary blood specimens.

Responsibilities

• Coordinate FDA-regulated studies with CRO partners and ensure protocol adherence per GCP.
• Lead day-to-day study execution, site coordination, and data collection.
• Manage study timelines, CAPA activities, and regulatory submissions.
• Oversee sample logistics, data integrity, and documentation for inspections.
• Develop and review validation protocols and regulatory documentation.

Skills

Project management

Cross-functional collaboration

Regulatory coordination

GCP compliance

FDA regulatory knowledge

Data interpretation

Statistical analysis

Scientific writing

Independent work

Education

PhD in Chemistry/related field

Master's degree with 7+ years

Bachelor's degree with 10+ years

Tools

Roche Cobas

SCIEX 4500MD LC-MS/MS

LC-MS/MS instrumentation

Job description

Hims & Hers seeks a Senior Scientist, Regulatory & Clinical Operations to own execution of FDA-regulated studies within our Central New Jersey laboratory. You will coordinate with CROs and drive studies from kickoff to completion, ensuring regulatory compliance and scientific rigor.

The ideal candidate combines bench science expertise with clinical study execution and thrives in a fast-paced environment, reporting to the Director of R&D for centralized leadership and regulatory oversight.