Staff Pathologist

POSITION SUMMARY:

In this position, the Pathologist will have clinical oversight of Natera's laboratory testing. You will 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 will also be responsible for the proper maintenance of the histology lab for FFPE tissue block processing, slide staining/coverslipping/scanning, and performance evaluation of the HistoTechs (HTs and/or HTLs) and other lab personnel.

PRIMARY RESPONSIBILITIES:

• Review patient specimens prior to testing in collaboration with other applicable stakeholders.

• Review clinical notes (e.g., chief complaint and treatment history) and pathology reports for tumor information (primary location, histologic type and sample location [primary vs metastatic]) and perform tumor circling on H&E slides for molecular testing; and help to identify an alternative optimal FFPE block(s) and/or tumor specimen if the current sample is inadequate.

• Review, approve, and sign-out reports for oncology testing, mainly on NGS platforms, but may also include SNP array analysis and other methodologies.

• Oversee the review of genetic and CNV variant data: interpret NGS and microarray 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 Clinical Consultant. The Clinical Consultant is responsible for ensuring:

  • the proper utility of our assays including sample selection, and test appropriateness,

  • 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.

• 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 post-analytic) 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.

QUALIFICATIONS:

• MD/DO degree and ABP board-certified/eligible in AP/CP and Molecular Genetic Pathology preferred.

• Qualified for unrestricted Medical License to practice in the state of CA (current California Medical License holder preferred)

• Qualified or Current Certificate of Qualification in Genetic Testing from the NYS CLEP required.

• Five or more years of experience in a CLIA-certified clinical laboratory setting analyzing, interpreting and reporting clinical genetic/genomic data (fresh MGP fellowship graduates will be considered as well).

• Knowledge of CAP, CLIA, California, and New York state regulations.

• Management experience required.

KNOWLEDGE, SKILLS, AND ABILITIES:

• 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.