Clinical Scientist Jobs

About The Position

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Serve as the primary clinical coordinator and point of contact for FDA-regulated studies, working directly with the contracted CRO.
• Own day-to-day execution of the study, 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.
• 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.
• 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 aligned with CLSI guidelines and regulatory expectations.
• Support sample processing and testing per study protocol using automated chemistry and immunoassay platforms and LC-MS/MS instrumentation.
• Evaluate performance characteristics of venous as well as capillary specimens collected via at-home devices.
• 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.

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO
• Company holidays
• Quarterly mental health days
• Comprehensive health benefits including medical, dental & vision
• Parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats