Medical Laboratory Director – CLIA Laboratory at Naveris

Waltham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Jan, 26

Salary

0.0

Posted On

04 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Oncologic Pathology, Laboratory Regulations, Leadership, Communication, Program Evaluation, Problem-Solving, Relationship-Building, Team Management, Quality Assurance, Regulatory Compliance, Clinical Oversight, Molecular Diagnostics, Patient Care, Training and Education, Continuous Process Improvement, Collaboration

Industry

Biotechnology Research

Description

About Us Would you like to be part of a fast-growing team that believes all patients should have access to advanced diagnostic technologies that enable early detection of cancer when it is most treatable? 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. Opportunity Naveris is seeking a Medical Laboratory Director to lead our CLIA laboratories in Massachusetts and North Carolina. Reporting to the CEO, the Laboratory Director is responsible for the overall clinical, scientific, regulatory and administrative activities of the CLIA laboratories. This includes ensuring compliance with all regulatory and accreditation requirements (such as CLIA, CAP and NY State CLEP), providing clinical guidance to ordering physicians and patients, ensuring the quality and accuracy of testing, and leading a team of laboratory professionals. The Medical Laboratory Director provides clinical oversight, interpretation of test results, and consultation with physicians and other healthcare providers. The Laboratory Director is responsible for quality assurance programs, monitoring laboratory performance, and implementing continuous process improvements. Personnel management, training, and fostering a culture of quality care are also key to success in this role. Operational leadership involves collaborating closely with the head of Laboratory Operations on strategies, budgeting, and evaluating new technologies within the laboratory. Job Requirements The Medical Laboratory Director must be qualified under the personnel regulations of The Clinical Laboratory Improvement Amendments of 1988 with a track record of successfully overseeing the scope, standards, and quality of clinical testing services. The Laboratory Director has the knowledge and skills in all relevant areas of practice which includes administration, training and education, research, and patient care. The Director stands responsible for ensuring the provision of accurate laboratory results made available in a timely fashion to enhance medical services to patients. The Director participates in all laboratory related managerial decisions and coordinates with the head of Laboratory Operations to guide the operation of the laboratory including selection of staff, choice of methods, purchase of equipment, quality assurance, quality control, safety, regulatory compliance, hours of operation, scheduling of staff, and utilization management. The Laboratory Director shall be aware of and perform the duties and responsibilities of the position consistent with current and future standards of accreditation of laboratories by CLIA, the College of American Pathologists, New York State Department of Health and any other relevant regulatory bodies. The addendum to this job description provides a detailed outline of all duties and requirements the Laboratory Director is responsible for. The addendum will be provided to candidates who are interviewing for the position. 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 Participation in clinical activities of multidisciplinary cancer care with ability to communicate directly with treating physicians and patients Knowledge, Skills & Abilities: Includes 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. Naveris is an Equal Opportunity Employer 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.

Responsibilities

The Medical Laboratory Director is responsible for the overall clinical, scientific, regulatory, and administrative activities of the CLIA laboratories. This includes ensuring compliance with all regulatory and accreditation requirements, providing clinical guidance, and leading a team of laboratory professionals.