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.

About the role

Laboratory Establishment and Compliance

• 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.

Operational Leadership

• 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.

Collaboration and Strategic Integration

• 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.

To Be Successful in the role you will need:

• 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.

Additionally you are:

• 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.

About 10x Genomics

At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world.

We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience.

Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference. 

Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law.

10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.