About this role
About the Role 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. What You'll Do
- Provide scientific, clinical, and regulatory oversight for all molecular diagnostic testing operations at NYGC, ensuring compliance with CLIA, NYS CLEP, CAP, and other regulatory standards.
- Lead the development, validation, and implementation of NGS-based diagnostic assays for constitutional genetics and oncology; review validation protocols, validation summaries, and performance characteristics for all new and modified assays.
- Oversee the laboratory Quality Management System (QMS), QA/QC programs, instrument maintenance records, and performance monitoring; manage proficiency testing programs and maintain state licenses across multiple states.
- Provide professional interpretation and sign-out of molecular diagnostic test results; support clinical consultation with ordering physicians and healthcare providers.
- Supervise laboratory personnel, ensure training, competency assessments, and continuing education; maintain on-site presence for effective oversight of laboratory operations.
- Participate in CLIA, CAP, and institutional working groups or committees as appropriate.
- Manage regulatory compliance with CLIA, NYS CLEP, CAP; oversee applications and maintenance of state laboratory licenses across multiple states. What We're Looking For
- 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).
- 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.
- Must maintain sufficient on-site presence to provide effective oversight of laboratory operations. Nice to Have
- Additional NYS Certificates of Qualification (e.g., oncology, infectious disease) preferred. Competencies (from the job description)
- 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 integrity and focus.
- Collaborative & Communicative: Models collaboration and teamwork; communicates clearly; respects diversity of perspective.
- Adaptable & Innovative: Embraces change; pursues improvements; takes initiative and is solution-oriented.
- Leader and Manager: Attracts and develops diverse talent; coaches and provides feedback; translates vision into action. Compensation & Benefits
- Salary and benefits are not disclosed in the posting.