Senior Scientist Regulatory & Clinical Operations
Overview
You will lead the clinical coordination for FDA-regulated studies at Hims & Hers, owning execution from kickoff to completion with a contracted CRO. You will work at the intersection of bench science and clinical study execution, translating regulatory rigor into practical decisions. The role is onsite in Central New Jersey, reporting to the Director of R&D. You will drive study timelines, ensure protocol adherence, and troubleshoot assay issues across Roche Cobas and SCIEX platforms. This position offers the chance to shape study design and regulatory compliance for a public health platform.
What You'll Do10
- 1Own day-to-day execution of FDA-regulated studies, coordinating with the contracted CRO on timelines, data collection, and protocol adherence.
- 2Coordinate sample logistics, including shipment documentation, tracking, and resolving discrepancies such as missing samples.
- 3Perform root cause analysis and support CAPA activities for study-related deviations.
- 4Develop and review study protocols, ensuring scientific rigor and compliance with design control and regulatory requirements.
- 5Coordinate human subjects protection, including IRB submissions and informed consent documentation.
- 6Identify technical and regulatory risks and implement mitigation strategies to maintain study timelines.
- 7Track study documentation, including case report forms and monitoring visit findings.
- 8Execute hands-on assays using Roche Cobas and LC-MS/MS instrumentation, supporting validation strategies like precision and linearity.
- 9Evaluate performance of venous and capillary specimens collected via devices like Tasso and YourBio Health.
- 10Author technical reports and validation documentation for regulatory submission, and present data-driven updates to leadership.
Requirements10
- 1PhD in Clinical Chemistry, Biochemistry, or related field with 4+ years; MS with 7+ years; or BS with 10+ years of bench experience in a diagnostic or clinical lab.
- 2Experience coordinating clinical or regulated studies with a CRO.
- 3Experience supporting FDA-regulated studies (e.g., 510(k), De Novo, PMA).
- 4Hands-on experience with assay development and execution lifecycle.
- 5Experience with venous and/or capillary blood specimen types.
- 6Ability to reconcile clinical sample data across tracking and laboratory systems.
- 7Strong project management skills with proven ability to manage study timelines.
- 8Ability to perform basic statistical analysis for study data interpretation.
- 9Working knowledge of QMS and design control processes (e.g., FDA QSR, ISO 13485).
- 10Excellent cross-functional communication skills.
Salary Insight
$130 - $150k per year
Location
Required Skills
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