CLIA Lab Director

Valius Sciences•San Francisco, CA

3d•Onsite

About The Position

Valius is building a diagnostics and bioinformatics company to power the future of cancer care, focusing on deep, comprehensive assessments of DNA, RNA, and protein. The company aims to provide patients and their care teams with the best possible understanding of how their tumor works and its vulnerabilities. In its first year, Valius worked with over 75 patients with challenging cancers, identifying plausible therapeutic targets not previously discovered. The company is scaling its patient volume and introducing new diagnostic modalities like single-cell transcriptomics. Having recently raised a $13.5M seed round, Valius is seeking passionate individuals to join its growing team and change cancer care. The CLIA Lab Director role is a foundational position at the intersection of cancer biology, multi-omic profiling, and precision medicine. The role involves leading the buildout and operation of Valius's first clinical laboratory, owning the design, accreditation, and day-to-day operations of a CLIA/CAP-certified lab, and establishing the infrastructure for high-complexity molecular diagnostics. This is an in-person role located in either San Francisco or Boston.

Requirements

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.

Responsibilities

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.
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.
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.
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.