Senior Scientist, Regulatory & Clinical Operations

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about http://hims.com/about and hims.com/how-it-works http://hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals http://www.hims.com/careers-professionals. ABOUT THE ROLE: Hims & Hers is seeking a Senior Scientist, Regulatory & Clinical Operations to join our growing laboratory organization. This individual contributor will report to the Director of R&D and serve as the clinical coordinator for our FDA-regulated study, working directly with our contracted CRO to own execution of 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. This is an on-site laboratory role based in Central New Jersey. YOU WILL: Clinical Study Coordination - Serve as the primary clinical coordinator and point of contact for the FDA-regulated studies, working directly with the contracted CRO - Own day-to-day execution of the study once it kicks off, including site coordination and protocol adherence in accordance with GCP requirements - Coordinate sample logistics with the CRO, including shipment documentation, tracking, and resolution of sample-related issues (e.g., missing samples, shipment discrepancies) - Coordinate with the CRO on study timelines, data collection, protocol deviations, and reporting - Perform root cause analysis and support Corrective and Preventive Action (CAPA) activities for study-related deviations - Develop and review study protocols, ensuring scientific rigor and compliance with design control and applicable regulatory requirements - Coordinate human subjects protection activities, including IRB submissions and approvals and informed consent documentation - Identify technical and regulatory risks and proactively develop mitigation strategies to maintain study timelines and compliance - Track and manage study documentation, including case report forms and monitoring visit findings Assay and Study Execution - Perform hands-on assay execution and testing in direct support of the regulated study - Support design of statistically robust validation strategies (e.g., precision, linearity, method comparison, LoB/LoD/LoQ, interference, stability) aligned with CLSI guidelines and regulatory expectations - Support sample processing and testing per study protocol using automated chemistry and immunoassay platforms (Roche Cobas or equivalent) and LC-MS/MS (SCIEX 4500MD or equivalent) instrumentation - Evaluate performance characteristics of venous as well as capillary specimens collected via at-home devices such as Tasso and YourBio Health - Troubleshoot study-related assay and technical issues in collaboration with the CRO and internal team Quality and Regulatory Collaboration - Partner with the Quality team to ensure study designs and documentation meet FDA, CAP, and CLIA requirements - Monitor study data for accuracy and integrity throughout the study lifecycle - Support laboratory inspection readiness and audit preparation activities related to the regulated study - Author and review technica…