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Lab Director (RTP) #2703



Durham, NC, USA
Posted on Wednesday, March 15, 2023
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
The Laboratory Director is responsible for supporting the CLIA laboratory director in providing oversight of the GRAIL CLIA Laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for ensuring compliance with the applicable regulations and accreditation requirements. The Lab Director may delegate certain responsibilities to other properly trained staff, but nonetheless has ultimate responsibility to ensure that all delegated duties are properly performed.

You will;

  • Responsible for developing and using a quality system approach to laboratory testing
  • Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing
  • Has been assigned the responsibility and authority to implement and maintain the College of American Pathologists (CAP) and New York State Department of Health (NYSDOH) standards
  • Ensure accurate and effective communication of laboratory data and appropriate patient result reporting to authorized recipients
  • May serve as the Clinical Consultant regarding the ordering of appropriate tests and clinical significance of laboratory data, as appropriate
  • Regularly attends meetings to discuss the management and operation of the laboratory
  • Interacts with the R&D teams to provide insights for new test development
  • Reviews and approves the technical performance validation and verification reports for new tests, instruments, and methods prior to being used for patient testing according to the requirements specified in CAP’s Checklists (Laboratory General, All Common, Molecular Pathology, Director Assessment and other relevant CAP checklists), NYSDOH standards, and other applicable regulations/standardsHours 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, instruments with moving parts, heating or freezing elements, and high speed centrifugation

Your background will include;

  • The GRAIL Laboratory Director (ALD) shall satisfy the applicable federal and state requirements and the guidelines issued by the CAP for high complexity testing as described in the following:
  • 42 CFR Subpart M Part 493.1443, Laboratory Director Qualifications
  • College of American Pathologists, Team Leader Assessment of Director and Quality Checklist
  • New York State, Title 10, NYCRR, Part 19: Clinical Laboratory Directors
  • Board Certified Pathologist with a NC Medical License or
  • Any MD with a NC Medical License and at least two (2) years in laboratory specialty training or PhD with ABMG certification in Clinical Molecular Genetics
  • At least 3 years of experience directing a molecular diagnostics laboratory or serving a technical supervisor in molecular diagnostic laboratory and will have or be eligible to obtain a New York State Certificate of Qualification in Oncology, Molecular and Cellular Tumor Markers
The expected, full-time, annual base pay scale for this position is $158,000 - $226,000. Actual base pay will consider skills, experience, and location.
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.