Laboratory Director

Summary

Join Natera as a Laboratory Director and provide clinical oversight for our laboratory testing, ensuring accurate and reliable patient results while adhering to regulatory standards. You will review and approve test reports, oversee data interpretation, and provide clinical and technical support. Responsibilities include setting testing standards, analyzing lab data, and potentially serving as a Clinical Consultant or Technical Supervisor. This leadership role requires managing a team, collaborating with other departments, and ensuring compliance with regulations. The position demands significant experience in clinical genetics and genomics, along with relevant certifications and a strong understanding of regulatory requirements.

Requirements

• MD/DO and/or PhD in genetics or related field required
• ABMGG board-certified in Clinical Cytogenetics and/or Molecular Genetics, ABP board-certified in Molecular Genetic Pathology, or equivalent doctoral-level board required
• Current California laboratory director license as a Clinical Genetic Molecular Biologist or Clinical Cytogeneticist required
• Current Certificate of Qualification in Genetic Testing from the NYS CLEP required
• 5 or more years of experience in a CLIA-certified clinical laboratory setting analyzing, interpreting and reporting clinical genetic/genomic data
• 5 or more years of experience in development and implementation of genetic variant interpretation processes and systems in line with published professional interpretation guidelines
• Knowledge of CAP, CLIA, California, and New York state regulations
• Management experience required
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire
• Must maintain a current status on Natera training requirements

Responsibilities

• Review and approve test reports for a variety of clinical molecular/cytogenetic and/or oncologic results, including NIPT, carrier screening, PGD/PGS, products of conception and oncology testing on platforms including SNP array analysis, NGS, and other methodologies
• Oversee the review and interpretation of genetic variation data: interpret variants detected by multiple technologies (e.g. NGS, microarray, qPCR, etc) in the context of medical literature, online variant databases and other references along with relevant patient demographic data
• Provide clinical and technical support for genetic counselors and other laboratory personnel
• Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained
• Analyze lab data, contribute to or write publications for high-quality scientific journals
• Ensure Test reports include pertinent information for test interpretation
• Ensure Availability for consultation concerning test results and the interpretation of those results as they relate to specific patient conditions
• Ensure Appropriate test method selection
• Ensure Adequate method validation to determine the accuracy and precision of the test
• Ensure Enrollment and active participation of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed in accordance with the CLIA requirements and: PT results are returned within established time frames
• Ensure PT reports are reviewed by the appropriate staff
• Ensure If applicable, corrective action plans are developed and executed for any unacceptable or unsatisfactory PT results
• Ensure Quality assessment and quality control programs are established and maintained
• Ensure Acceptable analytical test performance is established and maintained for each test system
• Ensure Remedial actions are taken and documented when significant deviations from the laboratory’s established performance characteristics are identified, and patient test results are reported only when the system is functioning properly
• Ensure Personnel have been appropriately trained and demonstrate competency prior to testing patient specimens
• Ensure Policies and procedures are established for monitoring personnel competency in all phases (preanalytical, analytical, and postanalytical) of testing to assure the ongoing competency of all individuals who perform testing
• Ensure Remedial training or continuing education needs are identified, and training provided
• Ensure an approved procedure manual is available to all personnel
• Review and approve assigned work; mentor and develop personnel, including dedicated succession planning and contingency management
• Work collaboratively with other departments

Preferred Qualifications

• Experience within a high-volume laboratory is preferred
• Additional variant interpretation experience and involvement in professional committees and/or organizations is preferred

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• A generous employee referral program