BillionToOne
Senior Director of Laboratory Operations – Oncology
BillionToOne, Menlo Park, California, United States, 94029
Senior Director of Laboratory Operations – Oncology
Ready to redefine what\'s possible in molecular diagnostics? BillionToOne is a company focused on transforming healthcare through transparent, collaborative, and innovative work in prenatal and cancer diagnostics. We are seeking an experienced
Senior Director of Laboratory Operations – Oncology
to lead the operational scale-up of our high-complexity oncology clinical laboratory, spanning CLIA operations, process engineering, reagent manufacturing, and automation, while ensuring quality and regulatory adherence. This role will partner with licensed Laboratory Directors to support clinical result interpretation, report sign-out, and regulatory compliance. This is a full-time, onsite position (3–5 days/week) in Menlo Park, CA. Responsibilities: Provide operational and strategic leadership across
CLIA laboratory operations, process engineering, reagent manufacturing, and automation . Ensure full compliance with
CLIA, CAP, NYSDOH
and other applicable regulations, maintaining inspection readiness and high-quality standards. Drive scaling initiatives to support rapid growth—leading automation rollouts, process improvements, and robust quality systems. Oversee workforce planning, training, and competency assessments to cultivate a high-performing, compliant team. Partner with licensed Laboratory Directors to facilitate clinical result interpretation, report sign-out, and regulatory submissions. Collaborate cross-functionally with
Product, R&D, Bioinformatics, and QA
to launch new tests and optimize assays. Lead budgeting, vendor management, and capital planning to drive operational efficiency and cost control. Foster a
positive, collaborative culture
that enables creativity and innovation while supporting one another. Requirements: PhD or equivalent
in genetics, molecular biology, bioengineering, or related field. 7+ years of clinical laboratory operations experience , including direct oversight in regulated environments (CLIA/CAP/NYSDOH). Proven track record of
scaling laboratory operations
in high-growth settings, including automation and process engineering leadership. Deep understanding of
CLIA regulations and quality systems , with evidence of inspection readiness and compliance leadership. Strong organizational and communication skills with the ability to influence across diverse teams. Experience building and leading positive, collaborative, high-performing teams . Experience in
budgeting, vendor management, and implementing operational systems
that enhance efficiency and cost-effectiveness. Nice-To-Haves: California licensure such as
CGMBS ,
CGMB , or MD/DO; eligibility considered. Board certification (ABMGG, ABP in Molecular Genetic Pathology, or equivalent). Hands-on experience with
oncology testing, variant interpretation , or
molecular assay development . At BillionToOne, we offer a total compensation package including base pay, equity options, bonus program, and industry-leading benefits. For this position, total compensation can be up to $462,120 per year, with a base pay range of $239,292 - $260,100 per year. BillionToOne is an equal opportunity employer. We do not discriminate on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. For more information about how we protect your information, we invite you to review our Privacy Policy. About BillionToOne
BillionToOne
is a next-generation molecular diagnostics company on a mission to make powerful diagnostic tests accessible to everyone. Our QCT molecular counting technology enhances disease detection resolution using cell-free DNA, transforming patient outcomes.
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Ready to redefine what\'s possible in molecular diagnostics? BillionToOne is a company focused on transforming healthcare through transparent, collaborative, and innovative work in prenatal and cancer diagnostics. We are seeking an experienced
Senior Director of Laboratory Operations – Oncology
to lead the operational scale-up of our high-complexity oncology clinical laboratory, spanning CLIA operations, process engineering, reagent manufacturing, and automation, while ensuring quality and regulatory adherence. This role will partner with licensed Laboratory Directors to support clinical result interpretation, report sign-out, and regulatory compliance. This is a full-time, onsite position (3–5 days/week) in Menlo Park, CA. Responsibilities: Provide operational and strategic leadership across
CLIA laboratory operations, process engineering, reagent manufacturing, and automation . Ensure full compliance with
CLIA, CAP, NYSDOH
and other applicable regulations, maintaining inspection readiness and high-quality standards. Drive scaling initiatives to support rapid growth—leading automation rollouts, process improvements, and robust quality systems. Oversee workforce planning, training, and competency assessments to cultivate a high-performing, compliant team. Partner with licensed Laboratory Directors to facilitate clinical result interpretation, report sign-out, and regulatory submissions. Collaborate cross-functionally with
Product, R&D, Bioinformatics, and QA
to launch new tests and optimize assays. Lead budgeting, vendor management, and capital planning to drive operational efficiency and cost control. Foster a
positive, collaborative culture
that enables creativity and innovation while supporting one another. Requirements: PhD or equivalent
in genetics, molecular biology, bioengineering, or related field. 7+ years of clinical laboratory operations experience , including direct oversight in regulated environments (CLIA/CAP/NYSDOH). Proven track record of
scaling laboratory operations
in high-growth settings, including automation and process engineering leadership. Deep understanding of
CLIA regulations and quality systems , with evidence of inspection readiness and compliance leadership. Strong organizational and communication skills with the ability to influence across diverse teams. Experience building and leading positive, collaborative, high-performing teams . Experience in
budgeting, vendor management, and implementing operational systems
that enhance efficiency and cost-effectiveness. Nice-To-Haves: California licensure such as
CGMBS ,
CGMB , or MD/DO; eligibility considered. Board certification (ABMGG, ABP in Molecular Genetic Pathology, or equivalent). Hands-on experience with
oncology testing, variant interpretation , or
molecular assay development . At BillionToOne, we offer a total compensation package including base pay, equity options, bonus program, and industry-leading benefits. For this position, total compensation can be up to $462,120 per year, with a base pay range of $239,292 - $260,100 per year. BillionToOne is an equal opportunity employer. We do not discriminate on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. For more information about how we protect your information, we invite you to review our Privacy Policy. About BillionToOne
BillionToOne
is a next-generation molecular diagnostics company on a mission to make powerful diagnostic tests accessible to everyone. Our QCT molecular counting technology enhances disease detection resolution using cell-free DNA, transforming patient outcomes.
#J-18808-Ljbffr