CLIA Lab Director roleWe'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 doLab 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
