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Co-Laboratory Director

Company: Guardant Health Inc.
Location: Redwood City
Posted on: September 16, 2020

Job Description:

Full-time

Company Description Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360® and GuardantOMNI® , for advanced stage cancer patients, which fuel its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection. Since its launch in 2014, Guardant360® has been used by more than 7,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

Job Description The Co-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 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:

Delegate the responsibilities of the General Supervisor, Clinical Consultant, Quality Systems Manager and Testing Personnel to employees who are qualified to perform such duties.

Responsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory test.

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 permit.

Must possess training and/or experience, 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: A physician who is currently certified by the American Board of Pathology in: Clinical Pathology; or Anatomic Pathology; or an area of special competence relevant to the certificate of qualification sought; or be a dentist who is currently certified by the American Board of Oral Pathology; or be a physician or hold an earned doctoral degree from an accredited institution with a relevant chemical, physical or biological science major; and

Is currently certified by: the American Board of Medical Microbiology; or the American Board of Clinical Chemistry in clinical chemistry; or the American Board of Clinical Chemistry in toxicology chemistry; or the American Board of Forensic Toxicology; or the American Board or Medical Laboratory Immunology; or the American Board of Internal Medicine in hematology; or

Subsequent to receiving a doctor of medicine, doctor of osteopathy or earned doctoral degree has had, and has documented to the department, four years of training and/or experience in an acceptable laboratory, including two or more years of training and/or experience in methods and techniques currently in use in the certificate category or categories sought and in general laboratory management, or an equivalent combination of training and/or experience as verified by the commissioner.

Additional Information 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 .

Keywords: Guardant Health Inc., Redwood City , Co-Laboratory Director, Other , Redwood City, California

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