Senior Laboratory Director, Oncology

BillionToOne•Menlo Park, CA

70d•$250,222 - $271,981•Onsite

About The Position

BillionToOne is seeking a Senior Laboratory Director, Oncology to lead and own the daily operations of its high-complexity oncology clinical laboratory. Reporting to the SVP of Laboratory Operations, this role has end-to-end accountability for oncology laboratory operations, including quality, turnaround time, capacity, cost, and regulatory compliance. It is described as a full-time, onsite role, with 2 to 3 days per week in Menlo Park, California. The director will build and scale the oncology laboratory organization, manage its operating budget and P&L, and drive performance against operational targets. The role also provides technical oversight of somatic variant interpretation and oncology report sign-out for Northstar liquid biopsy assays, troubleshoots technical issues across laboratory workflows, and ensures compliance with CLIA, CAP, and NYSDOH standards. The director will work with bioinformatics, R&D, and medical affairs on assay development and interpretation guidelines, serving as a subject-matter expert in oncology variant interpretation. BillionToOne is a molecular diagnostics company focused on making accurate diagnostic tests accessible. Its products include prenatal diagnostics and the Northstar liquid biopsy test for cancer treatment selection and monitoring.

Requirements

Doctoral degree (PhD, MD, or equivalent) in genetics, molecular biology, or a related field.
Board certification through ABMGG, ABP in Molecular Genetic Pathology, or equivalent.
Valid or eligible for a California Clinical Laboratory Director license (CGMB, CGMBS, or MD/DO licensure) and New York State CoQ in oncology testing.
At least 7 years of experience in a regulated clinical laboratory environment (CLIA/CAP/NYSDOH), including at least 4 years in molecular oncology testing with NGS.
Demonstrated experience developing, validating, and implementing oncology assays, such as somatic mutation panels and methylation assays.
Deep knowledge of cancer genomics, including tumor heterogeneity, somatic driver mutations, and targeted therapies.
Experience with variant interpretation databases such as COSMIC, OncoKB, and ClinVar; IGV and BAM file review; and molecular tumor boards.
Proficiency with LIMS and oncology bioinformatics tools.
Strong analytical, communication, and organizational skills, with a track record of leading teams in high-growth environments.

Responsibilities

Lead, build, and scale the oncology laboratory organization, including technologists, supervisors, and operations managers; manage headcount planning, hiring, and competency management.
Own the oncology laboratory operating budget and P&L, including cost of goods sold, operating expenses, and capital equipment planning.
Drive performance against turnaround-time, throughput, capacity, and quality targets; implement process improvements and automation to scale operations.
Lead laboratory scale-up, new-assay and instrument onboarding, inspection readiness, and vendor and capital procurement.
Provide technical oversight of somatic variant interpretation and oncology report sign-out from Northstar liquid biopsy assays, ensuring accuracy and timeliness.
Troubleshoot technical issues across oncology workflows, including liquid biopsy sample preparation, NGS library preparation, sequencing, and data analysis.
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.
Collaborate with bioinformatics, R&D, and medical affairs on assay development and interpretation guidelines.
Serve as a subject-matter expert on oncology variant interpretation, including AMP/CAP/NYS guidelines.

Benefits

Multiple medical benefit options; employee premiums are paid 100% for select plans, and dependents are covered up to 80%.
Family Bonding Leave for eligible employees: 16 weeks, paid at 100%.
Supplemental fertility benefits coverage.
Retirement savings program with a 4% company match.
Paid time off increases with tenure.
Latest hardware, lab equipment, and facilities.
Daily on-site lunches provided from local eateries.
On-campus state-of-the-art gym and restaurant.
Free on-site EV charging compatible with all EVs, including Tesla.
Annual bonus eligibility.
New-hire equity grant of up to $170,000 at grant value, vesting over four years, plus annual equity refresh grants equal in value to the new-hire grant.
Competitive medical and dental coverage.