Job Description

BillionToOne is seeking an experienced Molecular Genetics Clinical Laboratory Director or Senior Laboratory Director to provide technical leadership and oversee the daily operations of their high-complexity oncology clinical laboratory. The role involves ensuring accurate test results, maintaining regulatory compliance, driving quality improvements, and collaborating cross-functionally to advance oncology assays.

Responsibilities

• Provide technical oversight for oncology testing
• Interpret somatic variant results and sign out reports
• Troubleshoot technical issues in oncology workflows
• Evaluate lab performance and implement process improvements
• Review Non-Conforming Events and CAPAs
• Ensure compliance with CLIA, CAP, and other regulations
• Oversee documentation of SOPs and QC records
• Collaborate with bioinformatics, R&D, and medical affairs
• Participate in budget planning and manage lab expenses
• Support special projects like scaling new tests and preparing for inspections
• Serve as a subject matter expert on oncology variant interpretation

Requirements

• Doctoral degree (PhD, MD, or equivalent) in genetics, molecular biology, or related field
• Board certification (ABMGG, ABP in Molecular Genetic Pathology, or equivalent)
• California Clinical Laboratory Director license or eligibility
• New York State CoQ in oncology testing
• 4+ years in a regulated clinical laboratory environment (CLIA/CAP/NYSDOH)
• 3+ years in molecular oncology testing including NGS
• Leadership experience in developing and validating oncology assays
• Deep knowledge of cancer genomics
• Experience with variant interpretation databases and bioinformatics tools
• Strong analytical, communication, and organizational skills

Benefits

• No benefits