Director, CLIA Laboratory

10x Genomics•Pleasanton, CA

34d

About The Position

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. 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.