Description
Hims & Hers is seeking a Senior Scientist, Regulatory & Clinical Operations to join their laboratory organization. This role involves serving as the clinical coordinator for an FDA-regulated study, working directly with a contracted CRO to execute the study from kickoff through completion.
The ideal candidate is comfortable operating at the intersection of bench science and clinical study execution, translates regulatory rigor into practical day-to-day decisions, and thrives working independently in a fast-moving environment.
Responsibilities:
- 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, study timelines, data collection, and protocol deviations
- Perform root cause analysis and support Corrective and Preventive Action (CAPA) activities
- Develop and review study protocols, ensuring scientific rigor and compliance with regulatory requirements
- Coordinate human subjects protection activities, including IRB submissions and approvals
- Identify technical and regulatory risks and develop mitigation strategies
- Track and manage study documentation
- Perform hands-on assay execution and testing in support of the regulated study
- Support design of statistically robust validation strategies
- Evaluate performance characteristics of venous and capillary specimens
- Troubleshoot study-related assay and technical issues
- Partner with the Quality team to ensure study designs meet regulatory requirements
- Monitor study data for accuracy and integrity
- Support laboratory inspection readiness and audit preparation activities
- Author and review technical reports and validation documentation
- Develop and deliver data-driven presentations and study updates
Requirements:
- 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
- Demonstrated experience coordinating clinical or regulated studies
- Experience supporting FDA-regulated studies
- Hands-on experience across assay development and execution lifecycle
- 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
Preferred Qualifications:
- Experience validating capillary microsampling devices
- 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
- Familiarity with patient safety monitoring and adverse event reporting requirements
- Familiarity with emerging biomarker categories
- Hands-on familiarity with AI/ML tools
Benefits:
- Competitive salary & equity compensation
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits
- Employee Stock Purchase Program (ESPP)
- 401k benefits with employer matching contribution
- Offsite team retreats