Director, CLIA Laboratory

The Director of the CLIA Laboratory, reporting to the VP, Clinical Applications, will establish, lead, and operate 10x's first CLIA-certified laboratory, responsible for implementing and running novel diagnostic assays based on advanced single-cell and spatial technologies. This role requires an experienced laboratory leader who can build a CLIA lab from the ground up, implement quality and compliance systems, and ensure operational excellence across clinical testing workflows.

The ideal candidate has previously directed or played a senior leadership role in a CLIA-certified diagnostic laboratory, has successfully guided teams through CLIA, CAP, and state (including New York) accreditation processes, and has hands-on experience implementing and validating complex molecular assays such as NGS, multiplex imaging, or single-cell profiling.

• Lead the design, buildout, and commissioning of the 10x CLIA laboratory, ensuring readiness for clinical operations.
• Develop, implement, and maintain CLIA-compliant standard operating procedures (SOPs), policies, and documentation systems covering all laboratory processes.
• Oversee the establishment of quality management systems aligned with CLIA and CAP.
• Prepare and manage all aspects of laboratory accreditation, including CAP inspections, CLIA certification, and New York State approval.
• Partner with regulatory and quality teams to ensure full compliance with applicable federal and state regulations.

• Oversee day-to-day operations of the CLIA laboratory, ensuring timely, accurate, and compliant testing of clinical samples and reporting of results
• Implement laboratory information management systems (LIMS) and workflow automation to support scale and reproducibility.
• Manage assay onboarding from the Diagnostic Assay Development team, including technical transfer, performance verification, and documentation.
• Establish metrics for assay performance, turnaround time, and quality, ensuring continuous improvement.
• Lead and mentor a team of clinical laboratory scientists, supervisors, and technologists; provide training and competency assessments in accordance with CLIA and CAP requirements.

• Collaborate closely with the Diagnostic Assay Development team and the Clinical Bioinformatics team to transition new single-cell and spatial assays into clinical use.
• Partner with cross-functional teams in product development, quality assurance, and informatics to ensure readiness for clinical deployment.
• Serve as the laboratory's primary point of contact for external audits, partner inspections, and internal reviews.
• Participate in defining and executing the broader 10x clinical diagnostics roadmap, ensuring the lab supports research, clinical validation, and early commercial activities.

• PhD in molecular biology, clinical laboratory science, pathology, or related discipline.
• Board certification as a High-Complexity Laboratory Director (HCLD) under CLIA.
• Minimum 10 years' of experience in clinical laboratory operations, with 5 or more years in a leadership role overseeing CAP/CLIA-certified labs.
• Proven record of establishing or scaling clinical labs, including successful completion of CAP, CLIA, and New York State inspections.
• Experience implementing and validating advanced molecular diagnostic assays, such as NGS, single-cell, or multiplexed spatial assays.
• Deep understanding of quality systems, documentation control, and regulatory requirements for laboratory developed tests (LDTs).
• Proficiency in the analysis, interpretation, and reporting of high-complexity clinical assays, including NGS- and image-based data analysis
• Demonstrated ability to recruit, train, and lead laboratory staff in a high-complexity testing environment.

• Highly organized and methodical, with a focus on operational excellence and compliance.
• Thoughtful, hands-on leader with the ability to balance scientific innovation and regulatory discipline.
• Strong communicator, capable of engaging effectively with executives, regulators, and internal and external collaborators.
• Driven by building new capabilities and setting high standards for clinical quality and impact.

This is a foundational leadership position within 10x, responsible for creating the laboratory and operational foundation that will enable the clinical implementation of 10x's next-generation single-cell and spatial diagnostics. The Director of the CLIA Laboratory will ensure that 10x can deliver high-quality, compliant, and clinically meaningful results that advance precision medicine.