Laboratory Director

About this role

Associate/Laboratory Director of Oncology, Comprehensive Genomic Profiling

Position Summary

As an Associate Lab Director or Lab Director of Oncology, you have clinical oversight of Natera’s laboratory testing related to cancer testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results. You are responsible for ensuring the test validation and development meets all required regulatory standards. This position will be primarily responsible for technical and clinical performance of Natera’s comprehensive genomic profiling (CGP) assays. Title and scope of responsibility will be commensurate with the candidate’s experience. This position is on-site at Natera’s San Carlos, CA Laboratory.

Primary Responsibilities

• Provide clinical sign-out and interpretation for CGP reports, identifying actionable biomarkers and relevant clinical trials

• Provide technical and clinical support for laboratory staff, genetic counselors, and other clinical personnel

• Ensure acceptable levels of analytical performance for CGP assays, compliance with applicable standards, and laboratory inspection-readiness at all times

• Troubleshoot workflow and laboratory issues with clinical care and regulatory standards in mind

• Document findings and maintain accurate records consistent with Natera policies and procedures

May serve as Clinical Consultant. A Clinical Consultant is responsible for ensuring:

• Test reports include pertinent information for test interpretation, and

• Availability for consultation concerning test results and the interpretation of those results as they relate to specific patient conditions

Qualifications

• Education: MD/DO and/or PhD in genetics or related field required.

• Board Certification: ABMGG board-certified in Clinical Cytogenetics and/or Molecular Genetics, ABP board-certified in Molecular Genetic Pathology, or equivalent doctoral-level board required.

• Licensure:

• Current California laboratory director license as a Clinical Genetic Molecular Biologist or Clinical Cytogeneticist required. Candidates eligible for license may be considered.

• Current Certificate of Qualification in Genetic Testing from the NYS CLEP required. Candidates eligible for certification may be considered.

• Experience: Minimum of 5 years of experience in a CLIA-certified clinical laboratory setting analyzing, interpreting and reporting clinical genetic/genomic data.

• Regulatory Expertise: Deep, working knowledge of CAP, CLIA, California, and New York state regulations.

• Leadership: Demonstrated management experience in a high-throughput clinical laboratory environment.

Knowledge, Skills, and Abilities