• Review, approve, and sign-out reports for a variety of clinical molecular/cytogenetic and/or oncologic results, including NGS and other methodologies.
• Oversee the review of genetic and 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.

• Test reports include pertinent information for test interpretation
• Availability for consultation concerning test results and the interpretation of those results as they relate to specific patient conditions

• 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 (preanalytical, analytical, and postanalytical) 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.

• 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 an 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 Natera training requirements.

• MD/DO and/or PhD in genetics or related field required.
• ABMGG board certified- in Clinical Cytogenetics and/or Molecular Genetics, ABP board-certified in Molecular Genetic Pathology, or equivalent doctoral-level board required.
• Current California laboratory director license as a Clinical Genetic Molecular Biologist or Clinical Cytogeneticist required.
• Current Certificate of Qualification in Genetic Testing from the NYS CLEP required.
• 5 or more years of experience in a CLIA-certified clinical laboratory setting analyzing, interpreting and reporting clinical genetic/genomic data.
• Knowledge of CAP, CLIA, and applicable state regulations; including but not limited to California, and New York state regulations.
• Management experience required.

• Excellent written and oral communication skills.
• Experience leading a laboratory offering prenatal screening and oncology testing and evaluating, interpreting, and reporting out NGS and microarray data.
• Familiarity with next-generation sequencing, and/or knowledge of advanced methods of copy number detection.
• Strong background in human and medical genetics, and oncology with a familiarity of online human genomics.
• Understanding of statistical measures utilized in genetic testing and screening.

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