BillionToOne is seeking a
Senior Laboratory Director, Oncology 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.
Responsibilities: - Lead, build, and scale the oncology laboratory organization (technologists, supervisors, and operations managers), including headcount planning, hiring, and competency management.
- Own the oncology laboratory operating budget and P&L, including COGS, operating expenses, and capital equipment planning.
- Drive operational performance against turnaround-time (TAT), throughput, capacity, and quality targets; implement process improvements and automation to scale.
- 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 (liquid biopsy sample prep, 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 (AMP/CAP/NYS guidelines).
Qualifications:- 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).
- Valid or eligible for California Clinical Laboratory Director license (CGMB, CGMBS, MD/DO licensure) and New York State CoQ in oncology testing.
- 7+ years in a regulated clinical laboratory environment (CLIA/CAP/NYSDOH), with at least 4 years in molecular oncology testing including NGS.
- Proven leadership developing, validating, and implementing oncology assays (e.g., somatic mutation panels, methylation), with deep knowledge of cancer genomics (tumor heterogeneity, somatic driver mutations, targeted therapies).
- Experience with variant interpretation databases (COSMIC, OncoKB, 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.
Benefits And Perks:- Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
- Open, transparent culture that includes weekly Town Hall meetings
- The ability to indirectly or directly change the lives of hundreds of thousands patients
- Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered up to 80%
- Extremely generous Family Bonding Leave for eligible employees (16 weeks, paid at 100%)
- Supplemental fertility benefits coverage
- Retirement savings program including a 4% Company match
- Increase paid time off with increased tenure
- Latest and greatest hardware (laptop, lab equipment, facilities)
- Daily on-site lunches provided from top eateries
- A variety of perks on campus (state of the art gym, restaurant)
- Free on-site EV charging (compatible with all EVs, including Tesla)
At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based on experience and salary/equity options split that the candidate chooses), (2) generous equity options offering, (3) corporate bonus program, on top of (4) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave, etc.).
For this position, we offer a total compensation package of $471,554 per year, including a base pay range of $246,525 - $267,962 per year.
