Laboratory Director (Individual Contributor)
Company: Guardant Health
Location: Redwood City
Posted on: June 20, 2022
Job Description:
Company Description
Guardant Health is a leading precision oncology company focused on
helping conquer cancer globally through use of its proprietary
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 commercially launched Guardant360 -, Guardant360 CDx,
Guardant360 TissueNext---, Guardant360 Response---, and
GuardantOMNI - tests for advanced stage cancer patients, and
Guardant Reveal--- for early-stage cancer patients. These tests
fuel development of its screening program, which aims to address
the needs of asymptomatic individuals eligible for cancer
screening.
Job Description
The Laboratory Director is responsible for providing effective
clinical leadership for the delivery of laboratory services and
products. This position is responsible for clinical oversight of
all laboratory operations, including patient care, clinical trial,
and clinical research operations, and assuring that such operations
are conducted in compliance with applicable regulations. This
position is central to the operation of Guardant's multiple
next-generation sequencing 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.
Essential Duties and Responsibilities:
- 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 Guardant's laboratory
tests.
- 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 20 hours per week onsite to direct and
supervise the technical performance of the staff. Can be remote the
remainder of the time but must be readily available for
consultation to the laboratory's staff and clients
- 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
Practice Standards.
- 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
laboratory.
- Ensure that qualified personnel is employed; by defining the
qualifications and responsibilities of all laboratory technical
staff and documenting training and/or competency.
- Provide continuing education 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
skills.
- Specify in writing the technical and administrative
responsibilities and duties of all laboratory personnel, including
assist directors designated in the permit application(s) material
submitted to the Clinical Laboratory Evaluation Program. The
laboratory director is responsible for competency assessment of
direct-report supervisors. Documentation of assessments must be
performed annually and whenever new systems are introduced.
Remedial steps must be documented when staff do not perform as
expected.
- Promote a safe laboratory environment for personnel and the
public.
- Ensure that an approved procedure manual is available to all
personnel.
- 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
interpretation.
- Ensure that the laboratory is enrolled in the Department's
proficiency testing program for the testing performed and that the
laboratory adheres to the program's administrative and technical
requirements for all tests with no available New York State
proficiency test, ensure that the laboratory adopts an alternative
method to verify test accuracy and reliability.
- 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
identified.
- 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
they occur.
- 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.
Qualifications
- Must be a licensed physician in California (or is eligible for
licensure) or have an active California Laboratory Director
license.
- Must possess training and/or experience, obtained within the
previous six years, in generally accepted and currently used
methods and techniques in clinical molecular pathology. Experience
validating and signing out next-generation sequencing tests is
preferred.
- Must meet one of the following requirements:
- A physician who is currently certified by the American Board of
Pathology in: Clinical Pathology and/or Anatomic Pathology. Board
certification by the American Board of Pathology in Molecular
Genetic Pathology is a plus.
- Is currently certified by: the American Board of Medical
Genetics and Genomics in clinical molecular genetics; or American
Board of Bioanalysis.
- Preferable if qualified for New York State in the categories of
Oncology and Immunology
Additional Information
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
guidelines.
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.
Please visit our career page at:
http://www.guardanthealth.com/jobs/
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Keywords: Guardant Health, Redwood City , Laboratory Director (Individual Contributor), Executive , Redwood City, California
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