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Laboratory and Medical Director, Anatomic Pathologist (Part-Time)

Guardant Health

Any City, USHybridPosted 25 days ago$187,200 - $299,450/year
Part TimeDirector & AboveHealthcare & NursingDiagnostics
Original posting ↗

Summary

The Part-Time Laboratory and Medical Director is responsible for ensuring the delivery of quality clinical laboratory services and products within Guardant's Oncology Division. Specific responsibilities will include histology slide assessment, tissue selection, and sign-out, participation in laboratory operations, and improving digital pathology capabilities. Additional responsibilities include supporting clinical trial operations and assuring that such operations are conducted in compliance with the applicable regulations. This position is central to the operation of Guardant's multiple products in multiple different regulatory environments and will become even more so as Guardant moves into further in vitro diagnostic (IVD) development and into cancer screening.

Job description

Part-Time Schedule

40 hours every two weeks. The preferred schedule is five 8-hour workdays every two weeks.

Essential Duties and Responsibilities

  • Responsible for slide review for tumor content estimation, diagnosis correlation and communication with referring pathologists and oncologists if discrepancies arise, and interpretation of immunohistochemical stains, e.g. for PD-L1.
  • Participation in the quality management system, management of adverse outcomes and non-conformities, participation in onsite surveys, appropriate management of the results of the on-site survey and performance in proficiency testing.
  • Provide oversight of all aspects of the laboratory's quality management system to ensure conformance to requirements described in the Quality Management System chapter of the Clinical Laboratory Practice Standards.
  • Provide continuing education to laboratory technical staff that is relevant to laboratory medicine.
  • Ensure that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skills.
  • Promote a safe laboratory environment for personnel and the public.
  • Ensure that an approved procedure manual is available to all personnel.
  • Monitor all work performed in the laboratory to ensure that medically reliable data are generated.
  • Assure that the laboratory participates in monitoring and evaluating the quality and appropriateness of services rendered, within the context of the Quality Management System, regardless of where the testing is performed.
  • Provide advice to referring physicians regarding the significance of laboratory findings and ensure that reports of test results include pertinent information required for specific patient interpretation.
  • Effectively implement a plan of correction to deficiencies identified.
  • Report all concerns of test quality and/or safety to Supervisor or Safety Officer.
  • Review and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments, and reagent/control/instrument qualifications, quality audits, deviation approval requests, and nonconforming event reports.

Qualifications

  • Must be a Doctor of Medicine or Doctor of Osteopathy licensed to practice medicine or osteopathy in the State of California (or is eligible for licensure) and in the state of residence.
  • Must be a physician (M.D. or D.O.) that possess training and demonstrated expertise in histopathology, obtained within the previous six years, in generally accepted and currently used methods and techniques in one or more categories listed below and must meet one of the following requirements:
  • Be a physician who is currently certified by the American Board of Pathology in Anatomic Pathology.
  • Certification by the American Board of Pathology in Clinical Pathology and an area of special competence relevant to molecular genetics is preferable but not required.
  • Experience signing out IHC cases, particularly PD-L1.
  • Preferable if qualified for New York State in the categories of Oncology and Histopathology, or able to obtain said qualification.

Work Environment

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, heating or freezing elements, and high-speed centrifugation.

AI & Digital Fluency

Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.

Requirements

  • Doctor of Medicine or Doctor of Osteopathy licensed to practice medicine or osteopathy in the State of California (or eligible for licensure) and in the state of residence
  • Physician (M.D. or D.O.) with training and demonstrated expertise in histopathology obtained within the previous six years
  • Currently certified by the American Board of Pathology in Anatomic Pathology
  • Experience signing out IHC cases, particularly PD-L1
  • Certification by the American Board of Pathology in Clinical Pathology and an area of special competence relevant to molecular genetics is preferable but not required
  • Preferable if qualified for New York State in the categories of Oncology and Histopathology, or able to obtain said qualification

Company overview

Guardant Health, Inc. is a leading precision oncology company headquartered in Palo Alto, California, focused on transforming cancer care through advanced blood and tissue testing technologies. Founded in 2012 by Helmy Eltoukhy and AmirAli Talasaz, who serve as co-CEOs, the company specializes in liquid biopsy tests that detect cancer from circulating tumor DNA in blood samples. Guardant Health's flagship product, Guardant360, was the first comprehensive liquid biopsy test approved by the FDA for tumor mutation profiling and companion diagnostics in non-small cell lung cancer. The company has expanded its portfolio to include Guardant Reveal for residual disease monitoring, Guardant360 TissueNext tissue testing, and Shield, the first FDA-approved blood test for colorectal cancer screening. Guardant Health operates globally with approximately 1,999 employees and generates revenue from precision oncology testing services for clinical and biopharmaceutical customers, as well as development services and technology licensing. The company's innovative approach enables earlier cancer detection, treatment selection, and monitoring, helping to improve patient outcomes across all stages of cancer care.

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