Medical Laboratory Director – CLIA Laboratory

Naveris•Waltham, MA

About The Position

Naveris is seeking a Medical Laboratory Director to lead its CLIA laboratories in Massachusetts and North Carolina. This role is responsible for the overall clinical, scientific, regulatory, and administrative activities of the CLIA laboratories. The Director will ensure compliance with all regulatory and accreditation requirements (such as CLIA, CAP, and NY State CLEP), provide clinical guidance to ordering physicians and patients, ensure the quality and accuracy of testing, and lead a team of laboratory professionals. The position involves clinical oversight, interpretation of test results, and consultation with physicians and other healthcare providers. Key responsibilities include managing quality assurance programs, monitoring laboratory performance, implementing continuous process improvements, personnel management, training, and fostering a culture of quality care. The role also requires operational leadership, collaborating with the head of Laboratory Operations on strategies, budgeting, and evaluating new technologies.

Requirements

Qualified under the personnel regulations of The Clinical Laboratory Improvement Amendments of 1988.
Track record of successfully overseeing the scope, standards, and quality of clinical testing services.
Knowledge and skills in all relevant areas of practice: administration, training and education, research, and patient care.
At least 10 years in a high-complexity CLIA laboratory focused in molecular diagnostics.
At least 5 years in a leadership role.
Participation in clinical activities of multidisciplinary cancer care.
Ability to communicate directly with treating physicians and patients.
In-depth knowledge of oncologic pathology.
In-depth knowledge of laboratory regulations.
Strong leadership and communication skills.
Ability to evaluate programs.
Problem-solving skills.
Relationship-building skills.
Demonstrated ability to lead a diverse team of laboratory professionals.
Ability to build and maintain a strong laboratory culture with high employee morale and engagement.
Ability to work effectively in a corporate setting.
Ability to collaborate cross-functionally with non-laboratory and non-scientific personnel to advance Company objectives and enhance patient care.
Compliance with legal and regulatory requirements of HIPAA.
Acceptance and adherence to all policies and standards at Naveris.
Completion of HIPAA training.

Nice To Haves

Ph.D. in a relevant scientific field such as chemistry, biology, clinical laboratory science, or medical technology.
ABCC, ABMGG, and/or ABB certifications.
M.D., D.O., or M.D. with eligibility to hold valid Massachusetts and North Carolina medical licenses.
Eligibility to hold Certificate of Qualification in Oncology, Molecular and Cellular Tumor Markers issued by the New York State Department of Health.
Certification by the American Board of Pathology (ABP) in Anatomic Pathology and/or Clinical Pathology.
ABP certification in Molecular Genetic Pathology.

Responsibilities

Lead CLIA laboratories in Massachusetts and North Carolina.
Ensure compliance with all regulatory and accreditation requirements (CLIA, CAP, NY State CLEP).
Provide clinical guidance to ordering physicians and patients.
Ensure the quality and accuracy of testing.
Lead a team of laboratory professionals.
Provide clinical oversight and interpretation of test results.
Consult with physicians and other healthcare providers.
Manage quality assurance programs.
Monitor laboratory performance.
Implement continuous process improvements.
Oversee personnel management and training.
Foster a culture of quality care.
Collaborate with the head of Laboratory Operations on strategies, budgeting, and evaluating new technologies.
Participate in all laboratory-related managerial decisions.
Coordinate with the head of Laboratory Operations to guide laboratory operations, including staff selection, method choice, equipment purchase, quality assurance, quality control, safety, regulatory compliance, hours of operation, staff scheduling, and utilization management.
Ensure the provision of accurate laboratory results made available in a timely fashion to enhance medical services to patients.
Comply with legal and regulatory requirements of HIPAA and adhere to all policies and standards at Naveris.
Report any suspected violations or abuse of HIPAA.