Laboratory Director (Individual Contributor)

Company: Guardant Health
Location: Redwood City
Posted on: June 20, 2022

Job Description:

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. These tests fuel development of its screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.

Job Description

The Laboratory Director is responsible for providing effective clinical leadership for the delivery of laboratory services and products. This position is responsible for clinical oversight of all laboratory operations, including patient care, clinical trial, and clinical research operations, and assuring that such operations are conducted in compliance with applicable regulations. This position is central to the operation of Guardant's multiple next-generation sequencing 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.

Essential Duties and Responsibilities:

• Responsible for oversight of the operations and reporting of clinical next-generation sequencing tests
• Responsible for designing, validating, and maintaining the technical accuracy and medical reliability of Guardant's laboratory tests.
• Delegate the responsibilities of the General Supervisor, Clinical Consultant, Quality Systems Manager and Testing Personnel to employees who are qualified to perform such duties.
• Shall spend a minimum of 20 hours per week onsite to direct and supervise the technical performance of the staff. Can be remote the remainder of the time but must be readily available for consultation to the laboratory's staff and clients
• Participation in the quality management system, management of adverse outcomes and non-conformities, participation in the onsite survey, 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 effective and efficient administrative direction of the laboratory, including budget planning and controls in conjunction with the individual(s) responsible for financial management of the laboratory.
• Ensure that qualified personnel is employed; by defining the qualifications and responsibilities of all laboratory technical staff and documenting training and/or competency.
• 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.
• Specify in writing the technical and administrative responsibilities and duties of all laboratory personnel, including assist directors designated in the permit application(s) material submitted to the Clinical Laboratory Evaluation Program. The laboratory director is responsible for competency assessment of direct-report supervisors. Documentation of assessments must be performed annually and whenever new systems are introduced. Remedial steps must be documented when staff do not perform as expected.
• 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 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.
• Ensure that the laboratory is enrolled in the Department's proficiency testing program for the testing performed and that the laboratory adheres to the program's administrative and technical requirements for all tests with no available New York State proficiency test, ensure that the laboratory adopts an alternative method to verify test accuracy and reliability.
• Select all reference laboratories.
• Maintain an effective working relationship with applicable accrediting and regulatory agencies, administrative officials and the medical community.
• Effectively implement a plan of correction to deficiencies identified.
• Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of Clinical Laboratory services provided and to identify failures in quality as they occur.
• Ensure that a General Supervisor provides onsite supervision of high complexity test performance by testing.
• 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) or have an active California Laboratory Director license.
  • Must possess training and/or experience, obtained within the previous six years, in generally accepted and currently used methods and techniques in clinical molecular pathology. Experience validating and signing out next-generation sequencing tests is preferred.
  • Must meet one of the following requirements:
  • A physician who is currently certified by the American Board of Pathology in: Clinical Pathology and/or Anatomic Pathology. Board certification by the American Board of Pathology in Molecular Genetic Pathology is a plus.
  • Is currently certified by: the American Board of Medical Genetics and Genomics in clinical molecular genetics; or American Board of Bioanalysis.
  • Preferable if qualified for New York State in the categories of Oncology and Immunology
    
    Additional Information
    
    Covid Vaccination Policy: Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant's COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws. An employee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters.
    
    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 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.
    
    To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.
    
    Please visit our career page at: http://www.guardanthealth.com/jobs/
    
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Keywords: Guardant Health, Redwood City , Laboratory Director (Individual Contributor), Executive , Redwood City, California