Director, Molecular Diagnostics & NGS Leadership

New York Genome Center; City of Niagara Falls (NY); Híbrido; USD 300.000 - 320.000; Jornada completa

Descripción de la vacante

New York Genome Center in New York, NY, seeks a Director of Molecular Diagnostics to lead the clinical molecular diagnostics laboratory under CLIA and CAP accreditation. The Director provides clinical leadership, regulatory oversight, and directs assay development, validation, and reporting.

The role emphasizes quality management, staff competency, and interpretation of molecular diagnostic test results, with oversight across multiple states and ongoing staff development.

Formación

• MD or PhD in molecular biology, genetics, or related field.
• Board certification in Clinical Molecular Genetics or Molecular Genetic Pathology.
• New York State Certificate of Qualification (CQ) in Genetic Testing.
• Minimum 5 years of leadership experience in a molecular diagnostics laboratory with NGS oversight.
• Experience with assay validation, regulatory compliance, and quality systems.
• Experience directing labs performing constitutional genetics and molecular oncology testing.

Responsabilidades

• Provide scientific, clinical, and regulatory oversight for all molecular diagnostic testing operations.
• Ensure compliance with CLIA, NYS CLEP, CAP, and other standards.
• Lead development, validation, and implementation of NGS-based diagnostic assays.
• Review validation protocols and performance characteristics for new or modified assays.
• Ensure validation of FDA-cleared platforms and laboratory-developed tests (LDTs).
• Oversee the laboratory Quality Management System (QMS) and proficiency testing.
• Sign-out reports and provide clinical consultation with ordering physicians.

Conocimientos

Leadership

Regulatory compliance

Quality systems

Clinical interpretation

Molecular diagnostics

Educación

MD or PhD in molecular biology or related field

Board certification in Clinical Molecular Genetics or Molecular Genetic Pathology

New York State Certificate of Qualification in Genetic Testing

Descripción del empleo

New York Genome Center in New York, NY, seeks a Director of Molecular Diagnostics to lead the clinical molecular diagnostics laboratory under CLIA and CAP accreditation. The Director provides clinical leadership, regulatory oversight, and directs assay development, validation, and reporting.

The role emphasizes quality management, staff competency, and interpretation of molecular diagnostic test results, with oversight across multiple states and ongoing staff development.