Laboratory and Medical Director, Anatomic Pathologist (Part-Time

Guardant Health

1d • $217,800 - $299,450 • Hybrid

About The Position

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.

Requirements

• 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.
• Experience signing out IHC cases, particularly PD-L1.

Nice To Haves

• 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.

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.

Benefits

• The posted salary range reflects 100% FTE (40 hours per week). This position is 50% FTE and requires 40 hours of work every two weeks. The actual salary will be prorated based on the 50% FTE schedule

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree