CLIA Laboratory Director (Board Certified Molecular Pathologist, MD) #4328

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:

• MD or DO with Board Certification in Molecular Genetic Pathology (MGP) by the American Board of Pathology (ABP/ABMGG), and an active North Carolina medical license (or eligibility to obtain).
• Fellowship training in Molecular Genetic Pathology strongly preferred.
• Must meet all applicable federal (42 CFR Subpart M Part 493.1443), CAP, and New York State (Title 10, NYCRR, Part 19) requirements for directors of high-complexity clinical testing.
• Minimum of 3 years’ experience directing a molecular diagnostics laboratory or serving as a technical supervisor in a molecular diagnostics laboratory.
• Proven expertise in molecular diagnostics, including test interpretation, report review, and oversight of quality management systems.
• Strong leadership skills with experience ensuring compliance with CAP, CLIA, and NYSDOH standards.
• Eligible to obtain a New York State Certificate of Qualification in Oncology, Molecular and Cellular Tumor Markers.