Laboratory Director (Part-Time Basis, 20 Hours Weekly)

Company Description

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 Description

The Lab Director, Staff Pathologist, is responsible for ensuring the delivery of quality clinical laboratory services and products within Guardant’s Oncology Division. This position will serve as an associate director in a team of pathologists and laboratory directors. Specific responsibilities will include histology slide assessment, tissue selection, molecular assay interpretation and sign-out, assay development and validation, 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. 

Staff Pathologist Essential Duties and Responsibilities: 

• Associate director responsibilities in operating the Guardant Health histopathology laboratory under CLIA, CAP, NYS, and all other applicable regulations. 

• 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 licensed physician in California (or is eligible for licensure). 

• Must possess training and 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 and Clinical Pathology and preferably an area of special competence relevant to molecular genetics