Laboratory Medical Director, Molecular Pathologist

Guardant Health, Inc.; Redwood City (CA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Guardant Health, Inc. is seeking a Laboratory and Medical Director, Molecular Pathologist to provide clinical leadership for its molecular pathology laboratories.

The role oversees operations, regulatory compliance, and the development and validation of Guardant’s products across multiple locations and regulatory environments. The position requires directing testing quality, safety, and proficiency testing, with responsibility to act as temporary Laboratory Director in the absence of the license

Qualifications

• Provide effective clinical leadership for the delivery of molecular pathology laboratory services.
• Oversee testing across pre-analytic, analytic, and post-analytic phases to ensure quality results.
• Ensure compliance with applicable regulations and maintain high regulatory standards.
• Act as temporary Laboratory Director in the absence of the license holder, discharging onsite duties.

Responsibilities

• Lead the Molecular Pathology Laboratory operations and patient care oversight.
• Ensure testing systems deliver accurate and timely results across all tests.
• Maintain quality control and proficiency testing programs.
• Coordinate with regulatory bodies and internal stakeholders to ensure compliance.

Skills

Clinical leadership

Laboratory oversight

Quality control

Proficiency testing

Job description

Company Description

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn , X (Twitter) and Facebook .

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 app