Laboratory and Medical Director, Anatomic Pathologist; Part-Time

Position: Laboratory and Medical Director, Anatomic Pathologist (Part-Time
Location: Northern

## Laboratory and Medical Director, Anatomic Pathologist (Part-Time Apply:
Remote:
Remote - Open Position (USA):
Part time:
Posted Yesterday:
R-101231
** Company Description
** Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer.

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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.

** 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…