Senior Scientist, Regulatory & Clinical Operations
Job Location:
South Plainfield, NJ - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 were 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 and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit 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. 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 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 PhD in Clinical Chemistry Biochemistry Analytical Chemistry Molecular Biology or related field with 4 years; OR Masters degree with 7 years; OR Bachelors 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 Experience validating capillary microsampling devices (e.g. Tasso TAP) for regulated studies Experience with at-home or point-of-care diagnostic testing programs Experience with dried blood spot (DBS) workflows and stability characterization Experience with statistical analysis software (e.g. JMP Analyse-It) Experience with clinical data management and monitoring processes Familiarity with patient safety monitoring and adverse event reporting requirements for human subjects research Familiarity with emerging biomarker categories relevant to metabolic health longevity and consumer wellness testing Hands-on familiarity with AI/ML tools (e.g. Python Copilot Studio) for process improvement or data workflows 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 We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics wellness and a strong sense of belonging. If youre excited about this role we encourage you to applyeven if youre not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment including applicants with arrest or conviction records in accordance with the San Francisco Fair Chance Ordinance the Los Angeles County Fair Chance Ordinance the California Fair Chance Act and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability please contact us at and describe the needed accommodation. Your privacy is important to us and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status including disability. Please do not send resumes to this email address. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement. Required Experience: Senior IC
About Company
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