Senior Scientist, Regulatory & Clinical Operations

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 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 CROOwn day-to-day execution of the study once it kicks off, including site coordination and protocol adherence in accordance with GCP requirementsCoordinate 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 requirementsCoordinate 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 technical reports and validation documentation suitable for regulatory submission Develop and deliver data-driven presentations and study updates for internal leadership and external stakeholders Collaborate with Clinical Laboratory Operations during study transfer and implementation Serve as interim lab manager as needed, overseeing day-to-day lab operations You Have: 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, ideally in partnership with a CROExperience 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, with proven ability to manage study timelines and cross-functional coordination Ability to perform basic statistical analysis to support interpretation of study data Working knowledge of Quality Management Systems (QMS) and design control processes (e.g., FDA QSR, ISO 13485) Excellent cross-functional communication skills, with proven ability to present complex study data clearly to both technical and non-technical stakeholders Proven ability to work independently and drive study execution from kickoff to completion