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Senior Scientist, Regulatory & Clinical Operations

Hims & Hers· LABS
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South Plainfield, New Jersey$130k - $150kFull-timePosted 4mo ago

About the role

Senior Scientist, Regulatory & Clinical Operations to join the laboratory organization, acting as the clinical coordinator for FDA-regulated studies, partnering with a CRO to drive study execution from kickoff to completion in an on-site Central New Jersey lab.

Responsibilities

  • 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
  • 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
  • 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

Qualifications

  • 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 CRO
  • Experience 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

Skills

Required:Clinical Study CoordinationRegulatory Compliance (GCP, FDA QSR, CAP, CLIA)Assay Development & Execution

Benefits

  • Competitive salary & equity compensation for full-time roles
  • Unlimited PTO, company holidays, and quarterly mental health days
  • Comprehensive health benefits including medical, dental & vision, and parental leave
  • Employee Stock Purchase Program (ESPP)
  • 401k benefits with employer matching contribution
  • Offsite team retreats
Last updated Aug 12, 2026. Interested? Apply on the company site.

About Hims & Hers

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