Senior Laboratory Director, Oncology

<div class="content-intro"><h2><strong>A Rare Opportunity to Shape the Future of Genomics</strong></h2> <p>Join a team of brilliant, passionate innovators determined to transform healthcare. At BillionToOne, we've built a category-defining, publicly traded company on Nasdaq where transparency fuels trust, collaboration drives breakthroughs, and every contribution moves the needle on our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we build products that are 10x better than anything that exists today.</p> <p>Our scientists, engineers, sales executives, and visionaries are united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where cutting-edge science meets human compassion, and every innovation you contribute helps remove the fear of the unknown from some of life's most critical medical moments.</p> <p>If you're driven by purpose, energized by innovation, and ready to help shape the future of precision medicine at scale, this is where you belong.</p></div><p>BillionToOne is seeking a <strong>Senior Laboratory Director, Oncology</strong> to lead and own the daily operations of our high-complexity oncology clinical laboratory. Reporting to the SVP of Laboratory Operations, this person owns oncology laboratory operations end to end, with accountability for quality, turnaround time, capacity, cost, and regulatory compliance. This is a full-time, onsite role (2 to 3 days/week) in Menlo Park, CA.</p> <p><strong>Responsibilities: </strong></p> <ul> <li>Lead, build, and scale the oncology laboratory organization (technologists, supervisors, and operations managers), including headcount planning, hiring, and competency management.</li> <li>Own the oncology laboratory operating budget and P&L, including COGS, operating expenses, and capital equipment planning.</li> <li>Drive operational performance against turnaround-time (TAT), throughput, capacity, and quality targets; implement process improvements and automation to scale.</li> <li>Lead laboratory scale-up, new-assay and instrument onboarding, inspection readiness, and vendor and capital procurement.</li> <li>Provide technical oversight of somatic variant interpretation and oncology report sign-out from Northstar liquid biopsy assays, ensuring accuracy and timeliness.</li> <li>Troubleshoot technical issues across oncology workflows (liquid biopsy sample prep, NGS library preparation, sequencing, and data analysis).</li> <li> Ensure compliance with CLIA, CAP, and NYSDOH standards; oversee Non-Conforming Events, CAPAs, and documentation of SOPs, validations, QC records, competencies, proficiency testing, and report archives.</li> <li>Collaborate with bioinformatics, R&D, and medical affairs on assay development and interpretation guidelines; serve as a subject-matter expert on oncology variant interpretation (AMP/CAP/NYS guidelines).</li> </ul> <p><strong>Qualifications:</strong></p> <ul> <li>Doctoral degree (PhD, MD, or equivalent) in genetics, molecular biology, or a related field, with board certification (ABMGG, ABP in Molecular Genetic Pathology, or equivalent).</li> <li>Valid or eligible for California Clinical Laboratory Director license (CGMB, CGMBS, MD/DO licensure) and New York State CoQ in oncology testing.</li> <li>7+ years in a regulated clinical laboratory environment (CLIA/CAP/NYSDOH), with at least 4 years in molecular oncology testing including NGS.</li> <li>Proven leadership developing, validating, and implementing oncology assays (e.g., somatic mutation panels, methylation), with deep knowledge of cancer genomics (tumor heterogeneity,