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Hims & Hers, a NYSE-traded health and wellness platform, is seeking a Senior Scientist for Regulatory & Clinical Operations to lead FDA-regulated clinical study execution. This individual contributor role bridges bench science and clinical operations, reporting to the Director of R&D.
You will serve as the primary clinical coordinator for FDA-regulated studies, owning day-to-day execution from kickoff through completion in partnership with contracted CROs. Key responsibilities include: coordinating study sites and ensuring protocol adherence per GCP requirements; managing sample logistics including shipment documentation and discrepancy resolution; coordinating study timelines, data collection, and protocol deviation reporting; performing root cause analysis and CAPA activities; developing and reviewing study protocols for scientific rigor and regulatory compliance; coordinating IRB submissions and informed consent documentation; identifying and mitigating technical and regulatory risks; and tracking study documentation including case report forms.
You will also perform hands-on assay execution and testing in direct support of regulated studies using automated chemistry platforms (Roche Cobas) and LC-MS/MS (SCIEX 4500MD) instrumentation. You'll support design of statistically robust validation strategies aligned with CLSI guidelines, evaluate performance characteristics of venous and capillary specimens from at-home devices (Tasso, YourBio Health), and troubleshoot assay and technical issues collaboratively.
Additionally, you will partner with Quality teams to ensure study designs meet FDA, CAP, and CLIA requirements; monitor study data for accuracy and integrity; support laboratory inspection readiness and audit preparation; author and review technical reports for regulatory submission; develop data-driven presentations for leadership and stakeholders; and collaborate with Clinical Laboratory Operations during study transfer and implementation. You may serve as interim lab manager overseeing day-to-day operations as needed.
Required qualifications: PhD in Clinical Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology, or related field with 4+ years experience; 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. You must have demonstrated experience coordinating clinical or regulated studies with CROs, supporting FDA-regulated studies (510(k), De Novo, PMA pathways), hands-on assay development and execution experience, familiarity with venous and capillary blood specimens, ability to reconcile clinical sample data across systems, strong project management skills, basic statistical analysis capability, working knowledge of QMS and design control processes, and excellent cross-functional communication skills.
Preferred: experience validating capillary microsampling devices for regulated studies, at-home or point-of-care diagnostic testing programs, and dried blood spot workflows.
