Laboratory Director

4 weeks ago

Palo Alto, United States Guardant Health Full time

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.

Job Description

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.

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. Must be accessible to the Clinical Laboratory to provide onsite, telephone or electronic consultation as needed;
  5. Ensure that the testing systems provide quality laboratory services for all aspects of test performance;
  6. Guarantee appropriate physical and environmental conditions of the Clinical Laboratory;
  7. Ensure that test methodologies selected provide the quality of results required for patient care;
  8. Confirm that verification procedures are adequate to determine accuracy and precision;
  9. Verify that laboratory personnel are performing the test methods as required;
  10. Ensure participation in a suitable accuracy assessment program;
  11. Ensure quality control and quality assessment programs are established and maintained;
  12. Ensure establishment and maintenance of acceptable levels of analytical performance;
  13. Ensure that all necessary remedial actions are taken and documented;
  14. Ensure that reports of test results include pertinent information required for interpretation;
  15. Ensure consultation is available to the Clinical Laboratory’s clients;
  16. Ensure that a General Supervisor provides on-site supervision of high complexity testing;
  17. Ensure sufficient laboratory personnel are employed with appropriate education and experience;
  18. Ensure all personnel have the appropriate education and experience prior to testing patients’ specimens;
  19. Ensure that policies and procedures are established for monitoring individuals conducting testing;
  20. Ensure an approved procedure manual is available to all personnel;
  21. Ensure responsibilities and duties of each consultant and supervisor are specified in writing;
  22. Perform biennial review of Standard Operating Procedures;
  23. Report all concerns of test quality and/or safety to the Laboratory Supervisor or Safety Officer.
Qualifications

Must 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 by a board approved by HHS; OR

Before February 24, 2003, must have served as a director of a laboratory performing high complexity testing and must have at least two years of laboratory training or experience; and

Must fulfill requirements stated in 42 CFR 493.1443 and the College of American Pathologists Checklist.

Additional Information

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days. 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. 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.

All your information will be kept confidential according to EEO guidelines.

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