Laboratory Director

As the Associate/Laboratory Director, Oncology and one of our Laboratory Directors, you have clinical oversight of Natera’s laboratory 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.

PRIMARY RESPONSIBILITIES:

• Review, approve, and sign-out reports for a variety of clinical molecular/cytogenetic and/or oncologic results, including the Signatera MRD assay and other Next Generation Sequencing based assays.
• Oversee the review of genetic and CNV variant data: interpret NGS results in the context of medical literature, online variant databases and other references along with relevant patient demographic data.
• Provide clinical and technical support for genetic counselors and other laboratory personnel.
• Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained. 
• Analyze lab data, contribute to or write publications for high-quality scientific journals.
• May serve as Technical Supervisor. The Technical Supervisor is responsible for ensuring: appropriate test method selection; adequate method verification to determine the accuracy and precision of the test; enrollment of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed; PT samples are tested in accordance with the CLIA requirements; PT results are returned within the time frames established by the PT program; PT reports are reviewed by the appropriate staff; corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory; quality assessment and quality control programs are established and maintained; acceptable analytical test performance is established and maintained for each test system; remedial actions are taken and documented when significant deviations from the laboratory’s established performance characteristics are identified, and patient test results are reported only when the system is functioning properly; personnel have been appropriately trained and demonstrate competency prior to testing patient specimens; policies and procedures are established for monitoring personnel competency in all phases (preanalytic, analytic, and postanalytic) of testing to assure the ongoing competency of all individuals who perform testing; remedial training or continuing education needs are identified, and training provided; and an approved procedure manual is available to all personnel.

• Manage a team:  review and approve assigned work; mentor and develop personnel, including dedicated succession planning and contingency management.
• This role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) in order to perform the job.
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on all Natera training and qualification requirements.

QUALIFICATIONS:

• MD/DO and/or PhD in genetics or related field required.
• Current California license or eligibility as a Clinical Genetic Molecular Biologist Scientist or Clinical Cytogeneticist Scientist required.
• ABMGG board-certified in Molecular Genetics and/or Cytogenetics or Laboratory Genetics and Genomics or ABP board-certified in Molecular Genetic Pathology required.
• Current Certificate of Qualification in Genetic Testing and Molecular Tumor Markers from the NYS CLEP preferred.
• Two or more years of experience in a CLIA-certified clinical laboratory setting analyzing, interpreting and reporting clinical genetic/genomic data.
• Knowledge of CAP, CLIA, California, and New York state regulations.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Excellent written and oral communication skills.
• Experience leading a laboratory offering NGS based oncology testing and evaluating, interpreting, and reporting out NGS data.
• Familiarity with next-generation sequencing.
• Strong background in human and medical genetics, and oncology with a familiarity of human genomics.
• Understanding of statistical measures utilized in genetic testing and screening.