Laboratory Director, Histopathology (Not Remote)
Company: Guardant Health
Posted on: January 16, 2022
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. The Guardant
Health Oncology Platform leverages capabilities to drive commercial
adoption, improve patient clinical outcomes and lower healthcare
costs across all stages of the cancer care continuum. Guardant
Health has launched liquid biopsy-based Guardant360 -, Guardant360
CDx and GuardantOMNI - tests for advanced stage cancer patients.
These tests fuel development of 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.
The Laboratory Director is responsible for providing effective
clinical leadership for the delivery of laboratory services and
products within our Tissue Core team. This position is responsible
for clinical oversight of histopathology laboratory operations,
next-generation sequencing operations and reporting for patient
care, clinical trials, and clinical research operations, and
assuring that such operations are conducted in compliance with the
applicable regulations. The position will also contribute to the
development of digital pathology capabilities. 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.
Laboratory Director Essential Duties and Responsibilities:
- Responsible for operating the Guardant Health histopathology
laboratory under CLIA, CAP, NYS, and all other applicable
- Responsible for slide review for tumor content estimation,
diagnosis correlation, and immunohistochemistry testing, e.g. for
- Responsible for oversight of the operations and reporting of
clinical next-generation sequencing tests
- Responsible for designing, validating, and maintaining the
technical accuracy and medical reliability of the laboratory
- Collaborate as part of a cross-functional team on the
development of new NGS and histopathology products and
- Delegate the responsibilities of the General Supervisor,
Clinical Consultant, Quality Systems Manager and Testing Personnel
to employees who are qualified to perform such duties.
- Shall spend a minimum of 40 hours per week onsite to direct and
supervise the technical performance of the staff, review and sign
out histopathology and NGS cases.
- 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
- 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
- Ensure that qualified personnel are employed; by defining the
qualifications and responsibilities of all laboratory technical
staff and documenting training and/or competency.
- Provide continuing educational 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
- Promote a safe laboratory environment for personnel and the
- Ensure that an approved procedure manual is available to all
- 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
- Ensure that the laboratory is enrolled in proficiency testing
programs for the testing performed and that the laboratory adopts
an alternative method to verify test accuracy and reliability where
no commercial proficiency testing enrollment is possible.
- 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
- 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
- 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.
- Must be a licensed physician in California (or is eligible for
licensure) or have an active California Laboratory Director
- Must possess training and demonstrated expertise in
histopathology, 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
- Be a physician who is currently certified by the American Board
of Pathology in Anatomic Pathology
- Preferable if qualified for New York State in the categories of
Oncology and Histopathology.
- Board certification by the American Board of Pathology in
Clinical Pathology and/or Molecular Genetic Pathology is a
Covid Vaccination Policy: Starting January 7, 2022, Guardant Health
will require all employees to be fully vaccinated to either (a)
establish that they have been fully vaccinated against COVID-19; or
(b) request and obtain an approved exemption from Guardant's
COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as
consistent with applicable laws. An employee is considered fully
vaccinated against COVID-19 two weeks after receiving the second
dose of a two-dose vaccine or one dose of a single-dose
vaccination. Acceptable vaccines are approved or under emergency
use authorization by the U.S. Food and Drug Administration (FDA)
and/or the World Health Organization (WHO). In addition,
fully-vaccinated employees will be required to maintain their
fully-vaccinated status under this policy by obtaining, if
applicable, any FDA-approved boosters.
Employee may be required to lift routine office supplies and use
office equipment. Majority of the work is performed in a
desk/office environment; however, there may be exposure to high
noise levels, fumes, and biohazard material in the laboratory
environment. Ability to sit for extended periods of time.
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
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.
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Keywords: Guardant Health, Garland , Laboratory Director, Histopathology (Not Remote), Executive , Garland, Texas
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