Senior Lab and Medical Director, Computational Pathology

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. 

Senior Lab and Medical Director, Computational Pathology

As our Senior Lab and Medical Director, Computational Pathology, you would be responsible for providing effective clinical leadership for the delivery of laboratory services and products in the area of Computational Pathology.  You would also provide clinical oversight of laboratory operations on the Anatomic Pathology and Molecular Pathology services, including clinical signout for patient care, and assuring that such operations are conducted in compliance with the applicable regulations.  This role is central to the operation of Guardant’s multiple products in multiple different regulatory environments, and will become even more so, as Guardant further expands its portfolio into non-molecular clinical services.

Essential Duties and Responsibilities:

Computational Pathology Product Development (~75%)

• Define internal strategy for development of computational pathology services.
• Co-lead development of computational pathology services, in partnership with Technology and Product Development teams, by providing clinical and medical input into use case definition, ground-truth/annotation strategy, validation study design, regulatory submission support, clinical software workflows, and launch readiness.
• Provide input for manuscripts and posters related to new computational pathology products, in collaboration with Medical Affairs and other relevant internal and external teams.
• Participate in exploration of partnerships related to expansion of computational and molecular pathology services.
• Ensure that the testing systems developed and used for computational pathology services performed in the laboratory, or at reference laboratories, provide quality laboratory services for all aspects of test performance — pre-analytic, analytic, and post-analytic phases of testing.

Clinical Lab & Medical Directorship — Molecular & Anatomic Pathology (~25%)

Clinical Signout & Consultation

• Provide clinical case signout and final diagnostic interpretation for molecular and/or anatomic pathology cases within scope of practice and license.
• Be accessible to the Clinical Laboratory to provide onsite, telephone, or electronic consultation as needed.
• Ensure that consultation is available to the Clinical Laboratory's clients on matters relating to the quality of test results and reporting, and their interpretation concerning specific patient conditions.
• Ensure that reports of test results include pertinent information required for interpretation.

Laboratory Director Responsibilities

• Act as temporary Laboratory Director in his/her absence, fully discharging 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.
• Perform administrative duties for Laboratory and Medical Director, Technical Supervisor, Clinical Consultant, and Testing Personnel staff.
• Ensure all Clinical Laboratory duties are properly performed.
• Ensure a General Supervisor provides on-site supervision of high-complexity testing.

Quality, Safety & Test Systems

• Guarantee that the physical and environmental conditions of the Clinical Laboratory are appropriate for the testing performed, and provide a safe environment protecting employees 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, precisin, and other pertinent performance characteristics of the method.
• Verify that laboratory personnel are performing test methods as required for accurate and reliable results.
• 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 quality control and quality assessment programs are established and maintained to assure the quality of Clinical Laboratory services and to identify failures in quality as they occur.
• Report all concerns of test quality and/or safety to the Laboratory Supervisor or Safety Officer.
• Ensure an approved procedure manual is available to all personnel responsible for any aspect of the testing process.
• Perform biennial review of Standard Operating Procedures.

Proficiency Testing

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

• Results are returned within the timeframes established by the proficiency testing program;
• All proficiency testing reports received are reviewed by appropriate staff to evaluate laboratory performance and identify any problems requiring corrective action; and
• An approved corrective action plan is followed whenever any proficiency testing result is found unacceptable or unsatisfactory.

Personnel & Competency

• Ensure that a sufficient number of laboratory personnel are employed with appropriate education and experience/training to provide appropriate consultation, properly supervise, and accurately perform tests and report results in accordance with personnel responsibilities.
• Ensure that, prior to testing patient specimens, all personnel have appropriate education and experience, have received appropriate training for the type and complexity of services offered, and have demonstrated the ability to reliably perform all testing operations and report accurate results.
• Ensure that policies and procedures are established for monitoring individuals conducting pre-analytical, analytical, and post-analytical phases of testing, to assure competency is maintained, and to identify needs for remedial training or continuing education.
• Ensure that the responsibilities and duties of each consultant and supervisor, and each person engaged in the pre-analytic, analytic, or post-analytic phases of testing, are specified in writing — identifying which examinations/procedures each individual is authorized to perform, whether supervision is required, and whether supervisor or director review is required prior to reporting patient results.

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
• Prior industry experience at a diagnostics, biotech, or digital health company.
• Experience with whole-slide imaging platforms, image analysis software, or validation of AI/ML-based algorithms.
• Track record of peer-reviewed publications or conference presentations in pathology, oncology, or computational pathology.
• Experience contributing to regulatory submissions (510(k), PMA, or LDT validation packages).
• Familiarity with next-generation sequencing (NGS) and liquid biopsy testing.
• 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:

• Travel expectations: ~15%
• 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.

AI & Digital Fluency

• 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.

Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies.  Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients. 

The annualized base salary ranges for the primary location and any additional locations are listed below. This range does not include benefits or, if applicable, bonus, commission, or equity. Each candidate’s compensation offer will be based on multiple factors including, but not limited to, geography, experience, education, job-related skills, job duties, and business need. Primary Location: Remote - Open Position (USA) Primary Location Base Pay Range: $233,700 - $321,350 Other US Location(s) Base Pay Range: $233,700 - $321,350 If the role is performed in Colorado, the pay range for this job is: $205,200 - $282,150