The Laboratory and Medical Director, 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, participation in laboratory operations, and improving digital pathology capabilities. 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.

Laboratory Director Essential Duties and Responsibilities:

• Laboratory director responsibilities in operating the Guardant Health histopathology laboratory under 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. 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.