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BillionToOne, a publicly traded Nasdaq genomics company, is seeking a Senior Laboratory Director for Oncology to lead end-to-end operations of their high-complexity oncology clinical laboratory. Reporting to the SVP of Laboratory Operations, this role owns all aspects of oncology lab operations including quality, turnaround time, capacity, cost, and regulatory compliance.
Key responsibilities include leading and scaling the oncology laboratory team (technologists, supervisors, operations managers) with full accountability for headcount planning, hiring, and competency development. You will own the oncology laboratory operating budget and P&L, including COGS, operating expenses, and capital equipment planning. The role requires driving operational performance against turnaround-time, throughput, capacity, and quality targets while implementing process improvements and automation to scale operations.
You will lead laboratory scale-up initiatives, new-assay and instrument onboarding, inspection readiness, and vendor/capital procurement. Technical oversight includes somatic variant interpretation and oncology report sign-out from Northstar liquid biopsy assays, ensuring accuracy and timeliness. You'll troubleshoot technical issues across oncology workflows including liquid biopsy sample prep, NGS library preparation, sequencing, and data analysis.
Regulatory and compliance responsibilities are critical: ensuring adherence to CLIA, CAP, and NYSDOH standards; overseeing Non-Conforming Events and CAPAs; and maintaining documentation of SOPs, validations, QC records, competencies, proficiency testing, and report archives. Collaboration with bioinformatics, R&D, and medical affairs on assay development and interpretation guidelines is essential, with you serving as a subject-matter expert on oncology variant interpretation per AMP/CAP/NYS guidelines.
Required qualifications include a doctoral degree (PhD, MD, or equivalent) in genetics, molecular biology, or related field with board certification (ABMGG, ABP in Molecular Genetic Pathology, or equivalent). You must be valid or eligible for California Clinical Laboratory Director license (CGMB, CGMBS, MD/DO licensure) and New York State CoQ in oncology testing. A minimum of 7+ years in regulated clinical laboratory environments (CLIA/CAP/NYSDOH) is required, with at least 4 years in molecular oncology testing including NGS. Proven leadership in developing, validating, and implementing oncology assays with deep cancer genomics knowledge is essential. Experience with variant interpretation databases (COSMIC, OncoKB, ClinVar), IGV and BAM file review, molecular tumor boards, LIMS, and oncology bioinformatics tools is required. Strong analytical, communication, and organizational skills with a track record of leading teams in high-growth environments are critical.
This is a full-time, hybrid role requiring 2-3 days per week onsite in Menlo Park, CA.
