Senior Scientist, Regulatory & Clinical Operations

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 drive the end-to-end management of clinical studies while ensuring scientific rigor and strict compliance with regulatory standards.

Key facts

What you'll do

Coordinate clinical study operations as the primary point of contact for FDA-regulated studies, managing all interactions with the contracted Clinical Research Organization to ensure on-time execution and protocol fidelity.

Own the day-to-day execution of studies post-kickoff, overseeing site coordination, subject enrollment, and adherence to Good Clinical Practice (GCP) requirements while maintaining detailed documentation.

Manage complex sample logistics in partnership with the CRO, including chain-of-custody documentation, real-time tracking, and rapid resolution of discrepancies such as missing samples or shipping issues.

Sync closely with the CRO on evolving study timelines, data collection workflows, protocol deviations, and scheduled reporting to maintain transparency and mitigate delays.

Execute root cause analysis for any study deviations and lead Corrective and Preventive Action (CAPA) initiatives to prevent recurrence and protect study integrity.

Develop, review, and maintain study protocols, ensuring scientific accuracy, statistical robustness, and full compliance with FDA, CLIA, and CAP regulatory requirements.

Coordinate all human subjects protection activities, including Institutional Review Board (IRB) submission cycles, amendment approvals, and oversight of informed consent documentation processes.

Identify technical and regulatory risks early in the study lifecycle and design proactive mitigation strategies to preserve timelines and ensure continuous compliance.

Maintain comprehensive study documentation, including case report forms, source data verification records, and monitoring visit findings, to support audits and inspections.

Perform hands-on assay execution and testing to support regulated studies, working directly with automated chemistry platforms and mass spectrometry instrumentation.

Design and validate analytical strategies aligned with Clinical and Laboratory Standards Institute (CLSI) guidelines, focusing on precision, linearity, method comparison, limits of detection, and interference testing.

Process and test samples using state-of-the-art instrumentation such as Roche Cobas automated chemistry systems and SCIEX 4500MD LC-MS/MS platforms.

Evaluate performance characteristics of alternative sample types, including capillary specimens collected via at-home collection devices like Tasso and YourBio Health, to support diverse patient needs.

Troubleshoot assay failures, instrument anomalies, and procedural issues in real time through collaboration with the CRO and internal scientific teams to minimize study impact.

Partner with the Quality Assurance team to align study design, documentation, and execution with FDA, CAP, and CLIA standards during audits and inspections.

Monitor data quality across the entire study lifecycle, implementing data validation plans and resolving discrepancies to ensure regulatory-grade datasets.

Support laboratory inspection readiness by preparing standard operating procedures, training materials, and audit trails that demonstrate consistent compliance.

Author and review technical reports, validation summaries, and protocol deviation analyses suitable for regulatory submission and executive review.

Deliver clear, data-driven presentations and study updates to internal leadership, cross-functional partners, and external stakeholders to maintain alignment and support.

Collaborate with Clinical Laboratory Operations during study transfers, site implementations, and method validations to ensure seamless continuity.

Serve as interim lab manager as required, overseeing daily laboratory workflows, resource allocation, and team coordination to sustain operational excellence.

Requirements

Possess a Doctor of Philosophy in Clinical Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology, or a closely related scientific discipline with a minimum of four years of hands-on experience in regulated study execution.

Alternatively, hold a Master of Science degree with a minimum of seven years of progressively responsible bench and coordination experience in clinical or diagnostic settings.

Or bring a minimum of ten years of cumulative bench-level experience in clinical laboratory operations, demonstrating deep expertise in diagnostic testing and study coordination.

Demonstrate prior experience planning, coordinating, and executing clinical or regulated studies, preferably within a Contract Research Organization (CRO) environment.

Show a strong track record of supporting FDA-regulated submission pathways, including 510(k), De Novo classifications, or Premarket Approval (PMA) processes.

Have hands-on experience managing the full assay development and validation lifecycle, from method design through regulatory-aligned performance verification.

Possess practical experience performing testing on venous blood specimens and capillary blood specimens using automated chemistry instrumentation and mass spectrometry platforms.

Comfortable interpreting complex regulatory guidance and translating it into actionable operational procedures for laboratory staff and study teams.

Strong written and verbal communication skills to prepare detailed regulatory documents, interact with external auditors, and present findings to senior leadership.

Ability to manage multiple priorities in a fast-paced environment while maintaining meticulous attention to detail and adherence to compliance deadlines.

Self-motivated with strong problem-solving skills and the initiative to drive projects forward with minimal direct supervision.

Demonstrated commitment to quality, accuracy, and integrity in all aspects of laboratory operations and clinical study execution.

Nice to have

Prior experience with at-home sample collection devices and performance evaluation of capillary specimen results.

Knowledge of health and wellness industry regulations and commercial dynamics, including direct-to-consumer models.

Experience supporting cross-functional stakeholder engagement with Clinical, Product, and Regulatory teams.

Practical notes

This role is based on-site in Central New Jersey.

Applicants must be authorized to work in the United States without sponsorship for this position.

No remote or hybrid arrangement is available for this role.