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.

Job Responsibilities

• 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.

Assay Development and Validation

• 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.

Quality Management and Compliance

• 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.

Clinical Interpretation and Reporting

• 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.

Personnel Oversight

• 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.

Position Requirements

• 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.

Competencies

• Technical and Professional Skills: Consistently demonstrates skills and knowledge relevant for current role; strives to expand the depth and breadth of technical and professional skills; works with a high level of integrity; exhibits focus and discipline; appropriately prioritizes, manages expectations and delivers on commitments.
• Collaborative & Communicative: Models collaboration and teamwork; brings out the best in others; effectively works with all levels, internally and externally; respects and embraces diversity of perspective; communicates clearly and listens carefully; uses good judgment as to what to communicate and when to do so.
• Adaptable & Innovative: Adaptable and embraces change; develops new insights and pursues improvements and efficiency; fosters exchange of new ideas and willing to challenge the status quo; takes initiative and is solution-oriented; engages in work with passion and curiosity.
• Leader and Manager: Attracts, develops and retains diverse talent to achieve outstanding results; encourages professiona