Laboratory Director, Pathologist

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360, Guardant360 CDx, Guardant360 TissueNext, Guardant360 Response, and GuardantOMNI tests for advanced stage cancer patients, and Guardant Reveal for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield test, aims to address the needs of individuals eligible for cancer screening.
Job DescriptionPosition Summary: As the Laboratory and Medical Director, the employee is responsible for providing effective clinical leadership for the delivery of laboratory services and products. This position is responsible for clinical oversight of all laboratory operations, including patient care, clinical trial, and clinical research operations, and assuring that such operations are conducted in compliance with the applicable regulations. This position is central to the development, validation, and operation of Guardant's multiple products in multiple different locations and regulatory environments and will become even more so as Guardant moves into further in IVD development.
Essential Duties and Responsibilities: Act as temporary Laboratory Director in his/her absence, and at such time shall fully discharge the onsite duties and responsibilities of the Laboratory Director;Delegate the responsibilities of the Technical Supervisor, General Supervisor, Clinical Consultant, and Testing Personnel to employees who are qualified to perform such duties;Ensure all Clinical Laboratory duties are properly performed;Must be accessible to the Clinical Laboratory to provide onsite, telephone or electronic consultation as needed;Ensure that the testing systems developed and used for each test performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic and post-analytic phases of testing;Guarantee that the physical and environmental conditions of the Clinical Laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical and biological hazards;Ensure that test methodologies selected have the capability of providing the quality of results required for patient care;Confirm that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method;Verify that laboratory personnel are performing the test methods as required for accurate and reliable results;Ensure that the Clinical Laboratory participates in a suitable accuracy assessment (proficiency testing) program;Ensure that quality control and quality assessment programs are established and maintained to assure the quality of Clinical Laboratory services;Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system;Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the Clinical Laboratory's established performance characteristics are identified;Ensure that reports of test results include pertinent information required for interpretation;Ensure that consultation is available to the Clinical Laboratory's clients on matters relating to the quality of the test results reporting;Ensure that a General Supervisor provides on-site supervision of high complexity testing;Ensure that a sufficient number of laboratory personnel are employed with the appropriate education and experience;Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience;Ensure that all policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical, and post-analytical phases of testing;Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process;Ensure that the responsibilities and duties of each consultant and each supervisor are specified in writing;Perform biennial review of Standard Operating Procedures; andReport all concerns of test quality and/or safety to the Laboratory Supervisor or Safety Officer.QualificationsMust be a Doctor of Medicine or Doctor of Osteopathy licensed to practice medicine or osteopathy in the State of California; OR
Must be certified in Anatomic or Clinical Pathology, or both, by the American Board of Pathology or American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; OR
Have at least one year of laboratory training during medical residency; OR
Have at least two years of experience directing or supervising high complexity testing; OR
Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS; OR
Before February 24, 2003, must have served or be serving as a director of a laboratory performing high complexity testing and must have at least two years of laboratory training or experience; OR
Persons who on or before February 28, 1992, were qualified under State law to direct a laboratory in the State in which the laboratory is located.
Must fulfill requirements stated in 42 CFR 493.1443.
Must fulfill requirements stated in the College of American Pathologists Checklist.
Hours and days may vary depending on operational needs.
Standing or sitting for long periods of time may be necessary.
Additional InformationHybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays.
The US base salary range for this full-time position is $235,600 to $318,100. The range does not include benefits, and if applicable, bonus, commission, or equity.
Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to ******. Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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