Lab Director/Senior Lab Director - Oncology at BillionToOne

Menlo Park, California, United States

BillionToOne Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Biotechnology, DiagnosticsIndustries

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) and New York State CoQ in oncology testing
  • 4+ years in a regulated clinical laboratory environment (CLIA/CAP/NYSDOH), with at least 3 years in molecular oncology testing including NGS
  • Proven leadership in developing, validating, and implementing oncology assays (e.g., somatic mutation panels, methylation assays)
  • Deep knowledge of cancer genomics, including tumor heterogeneity, somatic driver mutations, and targeted therapies
  • Experience with variant interpretation databases (COSMIC, OncoKB, ClinVar), IGV, BAM file review, and molecular tumor board participation
  • Strong analytical, communication, and organizational skills, with a track record of leading teams in high-growth environments

Responsibilities

  • Provide technical oversight to ensure high-quality oncology testing and alignment with laboratory and clinical goals
  • Interpret somatic variant results from Northstar liquid biopsy assays, classify variants, and sign out oncology clinical reports
  • Troubleshoot technical issues related to oncology workflows, including liquid biopsy sample prep, NGS library preparation, sequencing, and data analysis
  • Evaluate lab performance, implement process improvements, and promote robust quality assurance systems
  • Review Non-Conforming Events and CAPAs to ensure timely resolution of issues impacting oncology test performance
  • Ensure compliance with CLIA, CAP, NYSDOH, and other applicable regulatory standards for oncology assays
  • Oversee accurate documentation of SOPs, validation reports, QC records, personnel competencies, proficiency testing, and report archives
  • Collaborate with bioinformatics, R&D, and medical affairs on assay development, interpretation guidelines, and continuous assay optimization
  • Participate in budget planning and manage lab expenses to ensure financial efficiency while maintaining exceptional quality
  • Support special projects, including scaling new oncology tests, preparing for inspections, and implementing automation
  • Serve as a subject matter expert on oncology variant interpretation, including AMP/CAP/NYS guidelines

Skills

Molecular Genetics
Oncology Testing
Liquid Biopsy
NGS
Somatic Variant Interpretation
Variant Classification
Clinical Reporting
Regulatory Compliance
Laboratory Management
Quality Improvement

BillionToOne

Molecular diagnostics for prenatal and oncology testing

About BillionToOne

BillionToOne specializes in molecular diagnostics within the healthcare sector, focusing on prenatal screening and oncology testing. Their proprietary QCT technology allows for the detection and quantification of diseases at a single base-pair resolution, enabling the identification of minute variations in DNA. The company offers two main products: Northstar Select™, which helps determine the best initial therapy for patients, and Northstar Response™, which tracks the effectiveness of that therapy. Unlike many competitors, BillionToOne emphasizes accuracy, efficiency, and accessibility in molecular testing, providing diagnostic services directly to healthcare providers. Their goal is to positively impact healthcare by making molecular testing more reliable and available to everyone.

Menlo Park, CaliforniaHeadquarters
2016Year Founded
$380.2MTotal Funding
SERIES_DCompany Stage
Biotechnology, HealthcareIndustries
201-500Employees

Benefits

Competitive pay
Retirement savings package
Parental leave
Free snacks & lunches
Medical, dental, & vision premiums
On campus perks
Free-on-site EV charging

Risks

Emerging biotech startups could threaten BillionToOne's market share.
Rapid technological advancements may render their current technology obsolete.
Expansion into new facilities may face operational challenges or delays.

Differentiation

BillionToOne's QCT technology detects DNA variations at single base-pair resolution.
Their UNITY Fetal Antigen NIPT is the first US cfDNA test for fetal antigen genotyping.
They replace invasive amniocentesis with a safe, affordable blood test for prenatal screening.

Upsides

BillionToOne achieved a billion-dollar valuation with a $130 million funding round.
Their new Austin facility will create 1,000 jobs, boosting production and local economy.
Recognition as Diagnostics Company of the Year highlights their industry leadership.

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