The Laboratory Director oversees the CLIA laboratory, ensuring compliance, quality management, and effective communication of laboratory data while leading investigations and audits.
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 493.1443, 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.
Top Skills
Clinical Laboratory Operations
Data Analysis
Molecular Diagnostics
Next-Generation Sequencing
Similar Jobs at GRAIL
.png)
Artificial Intelligence • Big Data • Healthtech • Machine Learning • Software • Biotech
Responsible for executing, maintaining and improving the quality management system for post-market quality elements, ensuring compliance and managing quality-related processes and improvements.
Top Skills:
21 Cfr 820CapCliaGoogle SuiteIso 13485Iso 14971Iso 15189IvdrMS OfficeVeeva Quality SuitesZoom
Artificial Intelligence • Big Data • Healthtech • Machine Learning • Software • Biotech
Manage a team overseeing engineering support for automation and laboratory equipment, ensuring compliance with regulations and continuous improvement.
Top Skills:
Customer Relationship Management (Crm) SoftwareGreen Button Go (Gbg)Laboratory Information Management Systems (Lims)Manufacturing Management Systems (Mes)
Artificial Intelligence • Big Data • Healthtech • Machine Learning • Software • Biotech
The Associate Director will manage all operations in the Clinical Laboratory, ensuring quality control, procedure implementation, and compliance with regulations, while providing leadership and communication to the team.
Top Skills:
Data ScienceLaboratory AutomationMolecular BiologyNext-Generation Sequencing
What you need to know about the Charlotte Tech Scene
Ranked among the hottest tech cities in 2024 by CompTIA, Charlotte is quickly cementing its place as a major U.S. tech hub. Home to more than 90,000 tech workers, the city’s ecosystem is primed for continued growth, fueled by billions in annual funding from heavyweights like Microsoft and RevTech Labs, which has created thousands of fintech jobs and made the city a go-to for tech pros looking for their next big opportunity.
Key Facts About Charlotte Tech
- Number of Tech Workers: 90,859; 6.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Lowe’s, Bank of America, TIAA, Microsoft, Honeywell
- Key Industries: Fintech, artificial intelligence, cybersecurity, cloud computing, e-commerce
- Funding Landscape: $3.1 billion in venture capital funding in 2024 (CED)
- Notable Investors: Microsoft, Google, Falfurrias Management Partners, RevTech Labs Foundation
- Research Centers and Universities: University of North Carolina at Charlotte, Northeastern University, North Carolina Research Campus
