Senior Director of Laboratory Operations – Oncology

Ready to redefine what's possible in molecular diagnostics?

Join a team of brilliant, passionate innovators who wake up every day determined to transform healthcare. At BillionToOne, we've built something extraordinary—a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we strive to build products that are 10x better than anything that exists today. Our people are our greatest asset: talented scientists, engineers, sales professionals, and visionaries united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where cutting-edge science meets human compassion—every innovation you contribute helps remove fear of unknown from some of life's most critical medical moments. If you're driven by purpose, energized by innovation, and ready to help build the future of precision medicine, this is where you belong.

We are seeking an experienced Senior Director of Laboratory Operations – Oncology to lead the operational scale-up of our high-complexity oncology clinical laboratory. This role will span CLIA operations, process engineering, reagent manufacturing, and automation—ensuring efficient expansion without compromising on quality or regulatory adherence. In addition, this leader will partner with licensed Laboratory Directors to support responsibilities such as 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 while maintaining inspection readiness and high-quality standards.
• Drive scaling initiatives to support rapid growth—leading automation rollouts, process improvements, and the implementation of 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 continuously optimize assays.
• Lead budgeting, vendor management, and capital planning to drive operational efficiency and cost control.
• Foster a positive, collaborative culture that empowers team members to go above and beyond, be creative and innovative, and support one another.

Requirements:

• Doctoral degree (PhD or equivalent) in genetics, molecular biology, bioengineering, or a 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 successful inspection readiness and compliance leadership.
• Strong organizational and communication skills, with demonstrated ability to inspire and influence across diverse teams and functions.
• Proven ability to build and lead positive, collaborative, high-performing teams where creativity, innovation, and mutual support are prioritized.
• Experience in budgeting, vendor management, and implementing operational systems that enhance efficiency and cost-effectiveness.

Nice-To-Haves:

• Valid or eligible California licensure (such as CGMBS, CGMB, or MD/DO); eligibility will also be considered.
• Board certification (ABMGG, ABP in Molecular Genetic Pathology, or equivalent).
• Hands-on experience with oncology testing, variant interpretation, or molecular assay development.

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 hundre