CLIA Laboratory Director (Board Certified Pathologist, NC Medical License)

Job Details
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges.
GRAIL is headquartered in Menlo Park, California, 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 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.
Responsibilities:

• Perform routine data review, interpretation and report release for commercially offered molecular diagnostic assays
• Act as subject matter expert for the clinical laboratory, leading investigations and troubleshooting initiatives as necessary
• Participate in process monitoring, clinical and market surveillance activities
• Review and approve documentation relevant to laboratory operations
• Be responsible for oversight and implementation of the laboratory quality management system including review of non-comformance documentation and participation in corrective/preventive action and change control boards
• Provide lab oversight with a focus on patient care across the preanalytic, analytic, and postanalytic phases of testing as dictated by 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
• Serve as Clinical Consultant regarding the ordering of appropriate tests and clinical significance of laboratory data, as appropriate
• Regularly attend meetings to discuss the management and operation of the laboratory
• Interact with the R&D teams to provide insights for new test development
• Review and approves the technical performance validation and verification reports for new tests, instruments, and methods prior to being used for patient testing
• Participate in routine audits of the clinical laboratory as lab director and medical subject matter expert

Preferred Qualifications:

• The GRAIL Laboratory Director 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 , Laboratory Director Qualifications College of American Pathologists, Team Leader Assessment of Director and Quality ChecklistNew 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.
• Fellow in Molecular Genetic Pathology preferred.
• 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

Physical Demands and Environment:

• 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

The expected, full-time, annual base pay scale for this position is $200,000 - $266,000 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 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.
Company
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
LEADERSHIP:
CEO: Bob Ragusa
Stock Exchange: NASDAQ
Stock Symbol: GRAL
Company info
Website Phone Location 1525 O'Brien Drive
Menlo Park
California
94025
United States
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