Medical Laboratory Director - CLIA Laboratory

1w1 week ago

Naveris

Waltham, US · Full-time · $200,000 – $350,000

About this role

Naveris is a commercial stage precision oncology diagnostics company dedicated to improving outcomes for viral-induced cancers through novel molecular diagnostics like the NavDx® test. The test monitors molecular residual disease in head & neck and anal cancers caused by HPV. Our high complexity labs are CAP accredited, NY DOH certified, and CLIA compliant.

The Medical Laboratory Director leads CLIA laboratories in Massachusetts and North Carolina, reporting to the CEO. Responsibilities include overall clinical, scientific, regulatory, and administrative activities. This role ensures compliance with CLIA, CAP, and NY State CLEP while providing clinical guidance to physicians and patients.

Day-to-day involves clinical oversight, test result interpretation, and consultation with healthcare providers. Lead quality assurance programs, monitor performance, and implement continuous process improvements. Foster a culture of quality care through personnel management and training.

Collaborate closely with the head of Laboratory Operations on strategies, budgeting, and new technologies. Join a fast-growing team enabling early cancer detection when most treatable. Participate in managerial decisions on staff, methods, equipment, safety, and utilization management.

Requirements

Qualified under personnel regulations of CLIA 1988 with track record of overseeing scope, standards, and quality of clinical testing
Knowledge and skills in administration, training and education, research, and patient care
Ensure provision of accurate laboratory results in a timely fashion to enhance patient medical services
Participate in laboratory managerial decisions including staff selection, choice of methods, equipment purchase
Oversee quality assurance, quality control, safety, regulatory compliance, hours of operation, and staff scheduling
Perform duties consistent with standards of CLIA, College of American Pathologists, and New York State Department of Health

Responsibilities

Lead overall clinical, scientific, regulatory, and administrative activities of CLIA laboratories
Ensure compliance with regulatory and accreditation requirements including CLIA, CAP, and NY State CLEP
Provide clinical guidance to ordering physicians and patients
Oversee interpretation of test results and consultation with physicians and healthcare providers
Ensure quality and accuracy of testing through quality assurance programs
Monitor laboratory performance and implement continuous process improvements
Lead team of laboratory professionals including personnel management and training
Collaborate with head of Laboratory Operations on strategies, budgeting, and evaluating new technologies