Director, Molecular Diagnostics (Clinical Laboratory) at New York Genome Center

New York, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Jul, 26

Salary

320000.0

Posted On

08 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Molecular diagnostics, Clinical laboratory leadership, Next-generation sequencing, Regulatory compliance, Quality management systems, Assay validation, Genetic testing, Molecular oncology, CLIA compliance, CAP accreditation, Personnel management, Clinical interpretation, NYS CLEP compliance, Laboratory operations, Strategic leadership

Industry

Biotechnology

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. About the New York Genome Center The New York Genome Center (NYGC) is an independent, nonprofit, academic research organization dedicated to advancing genomic research. NYGC scientists and staff are furthering new approaches to diagnosing and treating neurological diseases and cancer through their unique capabilities in whole genome sequencing, RNA sequencing, state-of-the art analytics, and the development of genomic tools. NYGC concentrates specifically on disease-based research in the following areas: neuropsychiatric disease (autism, schizophrenia, bipolar); neurodegenerative disease (ALS, Alzheimer’s, Parkinson’s, Huntington’s), and cancer. Located in Lower Manhattan, the New York Genome Center was founded by and remains closely affiliated with the leading academic medical centers and research universities in the New York region, engaging in research projects with and for these institutions. Essential to our collaborative work is an outstanding faculty, whose members typically hold a joint appointment at NYGC and a partner university. They support our scientific mission by conducting independent research in areas of mutual interest to us and the wider scientific community. Equal Opportunity We are committed to fostering a workplace environment that is welcoming and fair to all, ensuring that every employee has the opportunity to thrive. We believe that bringing together individuals with diverse backgrounds, experiences, and perspectives leads to greater collaboration, innovation, and discovery. Valuing and supporting each employee in reaching their full potential strengthens our organization and enhances our collective success. We recognize that creating an environment where all employees feel valued and included requires sustained effort and dedication from the entire organization. The New York Genome Center is a VEVRAA Federal Contractor. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, creed, color, gender, religion, national origin, sexual orientation, age, disability, genetic predisposition or carrier status, protected veteran or military status, domestic violence victim status, partnership status, caregiver status, alienage or citizenship status, marital status, or any other characteristic protected by applicable law. NYGC takes affirmative action in support of its policy to hire and advance in employment individuals who are protected veterans and individuals with disabilities. FLSA Status – Exempt This position is eligible for visa sponsorship and relocation assistance

Responsibilities

The Director provides clinical and scientific leadership for the molecular diagnostics laboratory, ensuring regulatory compliance and operational excellence. They are responsible for assay development, quality management, and the clinical interpretation and reporting of genetic and oncology test results.