Director, Molecular Diagnostics (Clinical Laboratory)

Job Description

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.

Job Responsibilities:

Laboratory Leadership and Oversight

• 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.

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.

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.

Don't meet every single requirement? At NYGC we are dedicated to building a diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyway. You may be just the right candidate for this or other roles.

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 professional development, coaches and regularly communicates expectations and feedback; aligns and inspires efforts toward our mission; translates organizational vision into action; responsibly utilizes NYGC's human and financial resources to ensure organizational and financial health; uses good judgment when making decisions; pushes boundaries and generates new ideas.

Work Flexibility

NYGC has established a flexible work policy to give employees and other staff more ability to balance their work, personal commitments, and commuting challenges. The incumbent in this position is eligible for a flexible work schedule or hybrid remote work arrangement with supervisory approval. It requires a minimum of two days per week onsite. Occasional evening and weekend work may be required.

Salary & Benefits

The pay range for this position is $300,000-320,000 per year; the base pay offered may vary depending on job-related knowledge, skills, and experience.

In addition, NYGC offers a full range of medical, financial, and other benefits as well as generous time off. This includes Medical/Dental/Vision for employees & dependent(s); Vacation, Holidays, Sick, and Other Leave, including a paid winter break; a 401(k) match; Life Insurance; Flexible Spending Accounts; employee Tuition Reimbursement; flexible schedules and telework options for some positions; an Employee Assistance Program; and much more.

FLSA Status - Exempt

This position is eligible for visa sponsorship and relocation assistance