Senior Laboratory Director, Oncology
BillionToOne
Summary
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.
Job description
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.
Requirements
- Doctoral degree (PhD, MD, or equivalent) in genetics, molecular biology, or a related field
- Board certification (ABMGG, ABP in Molecular Genetic Pathology, or equivalent)
- Valid or eligible for California Clinical Laboratory Director license (CGMB, CGMBS, MD/DO licensure)
- New York State CoQ in oncology testing
- 7+ years in a regulated clinical laboratory environment (CLIA/CAP/NYSDOH)
- At least 4 years in molecular oncology testing including NGS
- Proven leadership developing, validating, and implementing oncology assays
- 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
- Track record of leading teams in high-growth environments
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Parental Leave
- Equity Options
- Corporate Bonus Program
- Paid Time Off
- Fertility Benefits
- On-site Lunches
- On-site Gym
- Free EV Charging
Company overview
BillionToOne is a precision diagnostics company headquartered in Menlo Park, California, founded in 2016 with a mission to make molecular diagnostics more accurate, efficient, and accessible. The company has developed a proprietary Quantitative Counting Templates (QCT) molecular counting platform that can accurately count DNA molecules at the single-molecule level, enabling unprecedented sensitivity in disease detection. BillionToOne operates as a publicly traded company on NASDAQ under the symbol BLLN, having completed a successful IPO in 2025. The company's diagnostic platforms include UNITY Complete for non-invasive prenatal testing, which assesses fetal risk for recessive conditions and aneuploidies from a single maternal blood sample, and Northstar oncology products for cancer therapy selection and treatment response monitoring. With over 500 employees and multiple CLIA/CAP accredited laboratories, BillionToOne represents a significant advancement in quantitative molecular diagnostics, combining breakthrough science with scalable commercial operations to transform healthcare delivery.