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.

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.

• Must be a licensed physician in New York.
• Must 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 and preferably an area of special competence relevant to molecular genetics
  • Experience signing out IHC cases, particularly PD-L1.
  • Preferable if qualified for New York State Certificate of Qualification in the category of Histopathology, or able to obtain said qualification.

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

The US base salary range for this part-time position will be based on a prorated rate of a full-time employee (range for FTE: $221,400 to $298,900 The range does not include benefits, and if applicable, bonus, commission, or equity. The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role with the exception of any locations specifically referenced below (if any).

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

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Please visit our career page at: http://www.guardanthealth.com/jobs/

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