Lab Director/Senior Lab Director - Oncology at BillionToOne

Menlo Park, California, United States

Apply Now

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

Key technologies and capabilities for this role

Molecular GeneticsOncology TestingLiquid BiopsyNGSSomatic Variant InterpretationVariant ClassificationClinical ReportingRegulatory ComplianceLaboratory ManagementQuality Improvement

Questions & Answers

Common questions about this position

Is this role remote or onsite?

This is a full-time, onsite role requiring 2-3 days per week in Menlo Park, CA.

What salary or compensation does this position offer?

This information is not specified in the job description.

What key skills and experience are required for the Lab Director role?

The role requires experience in molecular genetics, interpreting somatic variant results from liquid biopsy assays, troubleshooting NGS workflows including sample prep, library preparation, sequencing, and data analysis, and ensuring compliance with CLIA, CAP, and NYSDOH standards.

What is the company culture like at BillionToOne?

BillionToOne fosters a culture of transparency that fuels trust, collaboration that drives breakthroughs, and values every voice in the mission to make life-changing diagnostics accessible, with talented scientists united by commitment to innovation and changing the standard of care.

What makes a strong candidate for this Lab Director position?

Strong candidates will have extensive experience as a Molecular Genetics Clinical Laboratory Director in oncology, expertise in variant interpretation and NGS workflows, proven ability to ensure regulatory compliance, and skills in cross-functional collaboration and process improvements.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free