Medical Laboratory Director – CLIA Laboratory

About the role

Naveris is a privately held, commercial stage, precision oncology diagnostics company dedicated to improving outcomes for the millions of people at risk of developing viral-induced cancers by developing novel molecular diagnostics that enable earlier cancer detection. Our flagship product, the NavDx® test, is used in routine clinical practice by thousands of physicians across the U.S. to monitor for molecular residual disease (MRD) of head & neck and anal cancers caused by the human papilloma virus. The NavDx test has been designated an Advanced Diagnostic Laboratory Test (ADLT) by CMS. Naveris operates high complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center and are certified under CLIA.

Responsibilities

• 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
• Lead a team of laboratory professionals
• Provide clinical oversight, interpretation of test results, and consultation with physicians and other healthcare providers
• Provide clinical oversight, interpretation of test results, and consultation with physicians and other healthcare providers
• Lead quality assurance programs, monitor laboratory performance, and implement continuous process improvements
• Manage personnel, train, and foster a culture of quality care
• Collaborate with the head of Laboratory Operations on strategies, budgeting, and evaluating new technologies within the laboratory

Qualifications

• Education: Ph.D. in a relevant scientific field such as chemistry, biology, clinical laboratory science, or medical technology. ABCC, ABMGG, and/or ABB certifications strongly desired
• M.D., D.O., or M.D. with eligibility to hold valid Massachusetts and North Carolina medical licenses is preferred
• 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 is preferred
• Experience: At least 10 years in a high-complexity CLIA laboratory focused in molecular diagnostics, including 5 years in a leadership role
• Knowledge, Skills & Abilities: In-depth knowledge of oncologic pathology, laboratory regulations, strong leadership and communication skills, ability to evaluate programs, problem-solving, and relationship-building. Demonstrated ability to lead a diverse team of laboratory professionals, building and maintaining a strong laboratory culture with high employee morale and engagement. The ability to work effectively in a corporate setting, collaborating cross-functionally with non-laboratory and non-scientific personnel to advance Company objectives and enhance patient care

Compliance Responsibilities

Health Insurance Portability and Accountability Act (HIPAA) is a federal law that describes the national standards to protect sensitive patient health information from being disclosed without the patient's consent or knowledge. All roles at Naveris require compliance with legal and regulatory requirements of HIPAA and acceptance and adherence to all policies and standards at Naveris. All personnel acknowledge they are personally responsible for reporting any suspected violations or abuse and are required to complete HIPAA training when joining the company.

Benefits

Naveris is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We don’t just accept differences - we celebrate and support them. We do not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.