CLIA Laboratory Director

Employer
GRAIL, Inc.
Location
Raleigh-Durham, NC, United States
Posted
May 04, 2021
Ref
1538717844
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
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. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

The Laboratory Director (LD) is responsible for overall oversight of the GRAIL CLIA Laboratory at RTP site, 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 LD may delegate certain responsibilities to other properly trained staff, but nonetheless has ultimate responsibility to ensure that all delegated duties are properly performed. LD will be reporting to the Senior Laboratory Director at Grail.

TASKS AND RESPONSIBILITIES

• 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 post analytical phases of testing
• Has been assigned the responsibility and authority to implement and maintain the College of American Pathologists (CAP) 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 their being used for patient testing according to the requirements specified in CAP's All Common Checklist, Molecular Pathology Checklist and other relevant CAP checklists
• 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, instruments with moving parts, heating or freezing elements, and high speed centrifugation

PREFERRED BACKGROUND

• The GRAIL Laboratory Director (LD) shall satisfy the applicable federal and state requirements and the guidelines issued by the CAP for high complexity testing as described in:
• 1) 42 CFR Subpart M Part 493.1443, Laboratory Director Qualifications
• 2) College of American Pathologists, Team Leader Assessment of Director and Quality Checklist
• 3) New York State, Title 10, NYCRR, Part 19: Clinical Laboratory Directors
• The LD of an RTP CLIA lab must be one of the following:
• 1) Board Certified Pathologist with a NC Medical License
• 2) Any MD with a NC Medical License and at least two years in laboratory specialty training, or,
• 3) a PhD with a NC specialist Director license
• At least 5 years of experience directing a molecular diagnostics laboratory and will have or be eligible to obtain a New York State Certificate of Qualification in Oncology, Molecular and Cellular Tumor Markers

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies ("Agency"), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings ("Agreement"). GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place. Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement. Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes. Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team .