Laboratory Medical Director, Molecular Pathologist

Guardant Health•Palo Alto, CA

50d•$217,800 - $299,450•Hybrid

About The Position

Guardant Health is seeking a Laboratory and Medical Director, Molecular Pathologist to provide effective clinical leadership for the delivery of molecular pathology laboratory services and products. This position is responsible for clinical oversight of all operations in the molecular pathology laboratories, including patient care, clinical trial, and clinical research operations, and assuring that such operations are conducted in compliance with applicable regulations. This role is central to the development, validation, and operation of Guardant’s multiple products in various locations and regulatory environments, and will become increasingly important as Guardant expands into IVD development.

Requirements

Must be a Doctor of Medicine or Doctor of Osteopathy licensed to practice medicine or osteopathy in the State of California; OR
Must be certified in Anatomic or Clinical Pathology, or both, by the American Board of Pathology or American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; OR
Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); OR
Have at least two years of experience directing or supervising high complexity testing; OR
Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS; OR
Before February 24, 2003, must have served or be serving as a director of a laboratory performing high complexity testing and must have at least two years of laboratory training or experience, or both; and two years of laboratory experience directing or supervising high complexity testing OR
Persons who on or before February 28, 1992, were qualified under State law to direct a laboratory in the State in which the laboratory is located.
Must fulfill requirements stated in 42 CFR 493.1443
Must fulfill requirements stated in the College of American Pathologists Checklist
Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.

Responsibilities

Ensure all Clinical Laboratory duties are properly performed.
Be accessible to the Clinical Laboratory for onsite, telephone, or electronic consultation as needed.
Ensure that the testing systems developed and used for each test performed in the laboratory provide quality laboratory services for all aspects of test performance, including the pre-analytic, analytic, and post-analytic phases of testing.
Guarantee that the physical and environmental conditions of the Clinical Laboratory are appropriate for the testing performed and provide a safe environment where employees are protected from physical, chemical, and biological hazards.
Ensure that test methodologies selected have the capability of providing the quality of results required for patient care.
Confirm that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method.
Verify that laboratory personnel are performing the test methods as required for accurate and reliable results.
Act as temporary Laboratory Director in the absence of the license holder Laboratory Director, fully discharging the onsite duties and responsibilities of the Laboratory Director.
Delegate responsibilities of the Technical Supervisor, General Supervisor, Clinical Consultant, and Testing Personnel to qualified employees.
Ensure that the Clinical Laboratory participates in a suitable accuracy assessment (proficiency testing) program and that results are returned within established timeframes.
Ensure all proficiency testing reports are reviewed by appropriate staff to evaluate laboratory performance and identify problems requiring corrective action.
Implement an approved corrective action plan when any proficiency testing result is found to be unacceptable or unsatisfactory.
Ensure that quality control and quality assessment programs are established and maintained to assure the quality of Clinical Laboratory services and identify failures in quality as they occur.
Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.
Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the Clinical Laboratory’s established performance characteristics are identified, and that patient results are reported only when the system is functioning properly.
Ensure that reports of test results include pertinent information required for interpretation.
Ensure that consultation is available to the Clinical Laboratory’s clients on matters relating to the quality of test results reporting and their interpretation concerning specific patient conditions.
Ensure that a General Supervisor provides on-site supervision of high complexity testing.
Ensure that a sufficient number of laboratory personnel are employed with the appropriate education and experience or training to provide appropriate consultation, properly supervise, and accurately perform tests and report test results in accordance with personnel responsibilities.
Ensure that prior to testing patients’ specimens, all personnel have the appropriate education and experience, received the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.
Ensure that all policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical, and post-analytical phases of testing to assure they are competent and maintain competency, and identify needs for remedial training or continuing education.
Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process.
Ensure that the responsibilities and duties of each consultant and supervisor, as well as each person engaged in the testing process, are specified in writing, identifying which examinations and procedures each individual is authorized to perform, whether supervision is required, and whether supervisor or director review is required prior to reporting patient test results.
Perform biennial review of Standard Operating Procedures.
Report all concerns of test quality and/or safety to the Laboratory Supervisor or Safety Officer.