Laboratory Medical Director, Molecular Pathologist

Laboratory and Medical Director, Molecular Pathologist 

Location: Redwood City, CA, USA (Hybrid, 3 days onsite in Redwood City, CA) 

Full-time 

Job Description 

As the Laboratory and Medical Director, the employee is responsible for providing 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 the applicable regulations.  This position is central to the development, validation, and operation of Guardant’s multiple products in multiple different locations and regulatory environments and will become even more so as Guardant moves further into IVD development.  

Essential Duties and Responsibilities:  

• Ensure all Clinical Laboratory duties are properly performed;  

• Must be accessible to the Clinical Laboratory to provide 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, which includes 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 in which 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, and at such time shall fully discharge the onsite duties and responsibilities of the Laboratory Director;  

• Delegate the responsibilities of the Technical Supervisor, General Supervisor, Clinical Consultant, and Testing Personnel to employees who are qualified to perform such duties;  

• Ensure that the Clinical Laboratory participates in a suitable accuracy assessment (proficiency testing) program and that:  

• The results are returned within the timeframes established by the proficiency testing program;  

• All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory’s performance and to identify any problems that require corrective action;

• An approved corrective action plan is implemented when any proficiency testing result is found to be unacceptable or unsatisfactory;  

• Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of Clinical Laboratory services provided to 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 the test results reporting and their interpretation concerning specific patient conditions;  

• Ensure that a General Supervisor provide on-site supervision of high complexity testing;  

• Ensure that a sufficient number of laboratory personnel are employed with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the 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 reliable 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 that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills;  

• 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 each supervisor, as well as each person engaged in the performance of the pre-analytical, analytic, and post-analytic phases of testing are specified in writing and identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisor or director review is required prior to reporting patient test results;   

• Perform biennial review of Standard Operating Procedures; and  

• Report all concerns of test quality and/or safety to the Laboratory Supervisor or Safety Officer.  

Qualifications 

• 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  

Work Environment:  

• Hours and days may vary depending on operational needs.  

• Standing or sitting for long periods of time may be necessary.  

• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high-speed centrifugation.  

Delegated Duties and Responsibilities:  

• Refer to assigned Delegation of Responsibilities Form