Director, Molecular Diagnostics; Clinical Laboratory

The Director of Molecular Diagnostics serves as the CLIA Laboratory Director for NYGC's clinical molecular diagnostics laboratory. This role provides clinical and scientific leadership for a CLIA-certified, CAP-accredited laboratory performing next-generation sequencing (NGS)-based genetic and oncology testing.

The Director is responsible for the clinical validity, regulatory compliance, and operational excellence of all laboratory testing activities. This includes oversight of assay development and validation, quality management systems, regulatory compliance, personnel competency, and clinical interpretation and reporting of molecular diagnostic tests.

The Director ensures compliance with CLIA, New York State Department of Health (NYS CLEP), CAP, and other applicable federal and state regulations, including licensure requirements for laboratories providing testing services across multiple U.S. states.

• Provide scientific, clinical, and regulatory oversight for all molecular diagnostic testing operations at NYGC.
• Ensure the laboratory operates in full compliance with CLIA, NYS CLEP, CAP, and other applicable regulatory standards.
• Maintain active oversight of laboratory operations through regular presence and engagement with laboratory staff.

• Lead the development, validation, and implementation of next-generation sequencing (NGS)-based diagnostic assays for constitutional genetics and oncology.
• Review and approve validation protocols, validation summaries, and performance characteristics for all new and modified assays.
• Ensure validation of both FDA-approved/cleared platforms and laboratory-developed tests (LDTs) in accordance with regulatory standards.

• Oversee the laboratory Quality Management System (QMS) including QA/QC programs, instrument maintenance records, and performance monitoring.
• Direct implementation and management of proficiency testing programs for genetic and oncology assays.
• Ensure ongoing compliance to maintain:
  • New York State certification (Genetic Testing; Molecular Oncology
    - Tumor and Cellular Markers)
  • CAP accreditation
  • CLIA certification
• Lead continuous quality improvement initiatives and participate in monthly quality assurance meetings.
• Oversee applications and maintenance of state laboratory licenses for laboratories providing testing services across multiple U.S. states.
• Participate in CLIA, CAP, and institutional working groups or committees as appropriate.

• Provide professional interpretation, review, and sign-out of molecular diagnostic test results.
• Ensure test reports meet clinical, regulatory, and laboratory standards.
• Serve as a resource for clinical consultation with ordering physicians and healthcare providers.

• Supervise laboratory personnel and ensure appropriate training, competency assessments, and continuing education.
• Ensure laboratory staffing and qualifications meet regulatory requirements.

This person must maintain sufficient on-site presence to provide effective oversight of laboratory operations. They must also be available for personal, telephone, or electronic consultation with laboratory personnel and clients.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change.

• MD or PhD in molecular biology, genetics, or a related field.
• Board certification in an appropriate specialty (e.g., Clinical Molecular Genetics and Genomics or Molecular Genetic Pathology).
• Possession of New York State Certificate of Qualification (CQ) in Genetic Testing required. Additional NYS Certificates of Qualification (e.g., oncology, infectious disease) preferred.
• Minimum 5 years of leadership experience in a molecular diagnostics laboratory, including oversight of clinical NGS testing and laboratory personnel.
• Demonstrated expertise in molecular diagnostics assay validation, regulatory compliance, and quality systems.
• Experience directing laboratories performing constitutional genetic testing and molecular oncology testing preferred.
• Experience managing laboratories licensed in multiple U.S. states preferred.

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