Senior Scientist, Regulatory & Clinical Operations

The role

This individual contributor will serve as the clinical coordinator for FDA-regulated studies. You will manage study execution from kickoff to completion and perform hands-on assay testing.

What you will do

• Serve as the primary clinical coordinator and point of contact for FDA-regulated studies
• Own day-to-day execution of the study including site coordination and protocol adherence
• Coordinate sample logistics with the CRO
• Coordinate with the CRO on study timelines, data collection, protocol deviations, and reporting
• Perform root cause analysis and support CAPA activities
• Develop and review study protocols
• Coordinate human subjects protection activities including IRB submissions
• Identify technical and regulatory risks and develop mitigation strategies
• Track and manage study documentation
• Perform hands-on assay execution and testing

Required qualifications

• PhD in Clinical Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology, or related field with 4+ years
• OR Master’s degree with 7+ years
• OR Bachelor’s degree with 10+ years of relevant bench experience in a diagnostic or clinical laboratory setting
• Demonstrated experience coordinating clinical or regulated studies
• Experience supporting FDA-regulated studies (e.g. 510(k), De Novo, or PMA pathways)
• Hands-on experience across assay development and execution lifecycle
• Experience with venous and/or capillary blood-based specimen types and other biological matrices
• Ability to reconcile clinical sample data across tracking and laboratory systems
• Strong project management and organizational skills
• Ability to perform basic statistical analysis
• Working knowledge of Quality Management Systems (QMS) and design control processes
• Excellent cross-functional communication skills

Nice to have

• Experience validating capillary microsampling devices (e.g., 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
• Experience with statistical analysis software (e.g., JMP, Analyse-It)
• Experience with clinical data management and monitoring processes
• Familiarity with patient safety monitoring and adverse event reporting requirements
• Familiarity with emerging biomarker categories relevant to metabolic health, longevity, and consumer wellness testing
• Hands-on familiarity with AI/ML tools (e.g., Python, Copilot Studio)

Benefits

• Competitive salary & equity compensation
• Unlimited PTO
• Company holidays
• Quarterly mental health days
• Comprehensive health benefits including medical, dental & vision
• Parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

About the company

Hims & Hers is a health and wellness platform that provides access to personalized care. It is a public company traded on the NYSE.