Laboratory Director, Pathologist

Laboratory Director, Pathologist (Hybrid, 3 days onsite in Redwood City, CA)

• Full-time

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through the 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.

Position 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 further in IVD development.

Essential Duties and Responsibilities:

1. 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;
2. Delegate the responsibilities of the Technical Supervisor, General Supervisor, Clinical Consultant, and Testing Personnel to qualified employees;
3. Ensure all Clinical Laboratory duties are properly performed;
4. Be accessible to the Clinical Laboratory to provide onsite, telephone, or electronic consultation as needed;
5. 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, including the pre-analytic, analytic, and post-analytic phases of testing;
6. Guarantee that the physical and environmental conditions of the Clinical Laboratory are appropriate for the testing performed and provide a safe environment;
7. Ensure that test methodologies selected have the capability of providing the quality of results required for patient care;
8. Confirm that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method;
9. Verify that laboratory personnel are performing the test methods as required for accurate and reliable results;
10. Ensure participation in a suitable accuracy assessment (proficiency testing) program;
11. Ensure quality control and quality assessment programs are established and maintained;
12. Ensure establishment and maintenance of acceptable levels of analytical performance for each test system;
13. Ensure that all necessary remedial actions are taken and documented whenever significant deviations from established performance characteristics are identified;
14. Ensure that reports of test results include pertinent information required for interpretation;
15. Ensure that consultation is available to the Clinical Laboratory’s clients on matters relating to the quality of the test results reporting;
16. Ensure that a General Supervisor provides on-site supervision of high complexity testing;
17. Ensure sufficient laboratory personnel are employed with the appropriate education and experience;
18. Ensure all personnel have the appropriate education and experience before testing patients’ specimens;
19. Ensure policies and procedures are established for monitoring individuals conducting testing phases to assure competency;
20. Ensure an approved procedure manual is available to all personnel responsible for any aspect of the testing process;
21. Perform biennial review of Standard Operating Procedures;
22. Report all concerns of test quality and/or safety to the Laboratory Supervisor or Safety Officer.

Minimum Requirements:

• Must be a Doctor of Medicine or Doctor of Osteopathy licensed to practice in 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
• 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 relevant science and be certified by a board approved by HHS; OR
• Must have served as a director of a laboratory performing high complexity testing before February 24, 2003, with two years of laboratory training or experience.

Must fulfill requirements stated in 42 CFR 493.1443 and 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. May be exposed to hazardous materials, blood specimens, and instruments with moving parts.

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days. All U.S. employees living 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. This range does not include benefits, and if applicable, bonus, commission, or equity. Individual pay is determined by work location and additional factors.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities. If you need support, please reach out to Peopleteam@guardanthealth.com.

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.

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