CLIA Lab Director

CLIA Lab Director Valius Sciences San Francisco, CA Job Details Full-time $200,000 - $300,000 a year 11 hours ago Benefits Health insurance Dental insurance 401(k) Vision insurance Qualifications Regulatory inspections Doctor of Medicine Laboratory procedures Medicine Molecular Biology Next generation sequencing Operations management Procedural guides Specimen collection / processing Regulatory compliance Employee retention Laboratory information management systems Corrective and preventive actions (CAPA) Quality management 8 years Laboratory staff training Team development Clinical staff training Laboratory regulatory affairs Quality control documentation Doctor of Philosophy Team management Medical laboratory work Clinical staff recruitment CLIA regulations Recruiting Laboratory staff supervision Quality systems Commissioning phase involvement Senior level Cross-functional collaboration Leadership Communication skills Molecular biology Regulatory compliance management Cross-functional communication Training delivery Senior leadership Staff development Assays Full Job Description Valius overview Valius is building the next generation of precision oncology, helping cancer patients and their physicians make more informed treatment decisions through comprehensive molecular testing and rigorous scientific analysis. In our first nine months, we've worked with close to 50 patients, identifying plausible therapeutic targets in the vast majority of cases. We've just raised a $10M seed round, led by 8VC and Basis Set Ventures, and are looking for folks passionate about changing cancer care to join our growing team. CLIA Lab Director role We're hiring a Lab Director to join our team in San Francisco to lead the buildout and operation of Valius's first clinical laboratory. This is a foundational role at a company at the intersection of cancer biology, multi-omic profiling, and precision medicine. You'll own the design, accreditation, and day-to-day operations of our CLIA/CAP-certified lab, establishing the infrastructure that will enable delivery of high-complexity molecular diagnostics directly to our cancer patients and their care teams. This is a rare opportunity to build something from the ground up in a mission-driven environment. This is an in-person role in either San Francisco or Boston. What you'll do Lab design and buildout Lead the end-to-end design, buildout, and commissioning of Valius's CLIA laboratory, from physical space planning through instrument installation and workflow validation Define lab infrastructure requirements including equipment, consumables, LIMS, and workflow automation to support clinical-grade reproducibility and scale Establish and document standard operating procedures (SOPs), quality management systems (QMS), and training programs from the ground up Accreditation and compliance Prepare and manage all aspects of laboratory accreditation, including CAP inspection readiness, CLIA certification, and New York State approval Serve as the CLIA Laboratory Director of record, taking responsibility for all aspects of laboratory compliance across pre-analytic, analytic, and post-analytic phases Laboratory operations Direct day-to-day clinical lab operations, ensuring timely, accurate, and compliant processing of patient samples and reporting of results Oversee implementation and validation of complex molecular assays, including 10x Genomics next-generation single-cell and spatial RNA sequencing Manage technical transfer of assays from R D into clinical operations Implement metrics for assay performance, turnaround time, and quality Team and cross-functional leadership Recruit, train, and lead a team of clinical laboratory scientists, supervisors, and technologists; conduct competency assessments in line with CLIA requirements Collaborate closely with computational biologists and translational scientists to integrate lab outputs into patient-facing reports Partner with bioinformatics and operations teams to ensure data integrity and compliant reporting of high-complexity results Contribute to scientific and operational strategy as a senior leader within Valius What you'll bring Advanced degree (PhD, MD, or MD/PhD) in a relevant scientific discipline (molecular biology, genomics, clinical laboratory science, or related field) Eligibility to serve as a High-Complexity Laboratory Director under CLIA regulations (HCLD board certification, or an MD/PhD with the required training and experience per 42 CFR Part 493) Minimum 8-10 years of experience in clinical laboratory operations, with at least 5 years in a leadership or director-level role overseeing a CAP/CLIA-certified laboratory Proven track record of successfully establishing or scaling a clinical lab Expert-level experience implementing and validating advanced molecular diagnostic assays such as bulk RNA sequencing, whole exome sequencing, and/or single-cell RNA sequencing using a 10x Genomics platform Deep working knowledge of quality systems, documentation control, and regulatory requirements for LDTs, including SOPs, CAPA processes, and proficiency testing programs Experience with LIMS platforms, electronic quality management systems (eQMS), and workflow automation in a high-complexity testing environment Strong ability to recruit, develop, and retain scientific staff Excellent written and verbal communication skills; ability to translate complex laboratory data into clear, actionable information for clinical, scientific, and executive stakeholders Commitment to our patient-focused mission Interest in working for a small, early-stage startup What we'll bring Competitive salary and equity compensation Generous refresh grants Comprehensive benefits (health, dental, vision, 401(k)) Genuine investment in your professional development Fun, mission-driven team culture

Compensation Range:

$200K - $300K