Innovation and leadership is in our DNA.
Variantyx provides cutting-edge diagnostic tools coupled with cross company teamwork to foster a meaningful and exciting career applying genomic medicine to diagnose patients with rare disease. For the last 7 years Variantyx has established itself as the industry leader in clinical genomic sequencing and interpretation as the first diagnostic lab to provide a comprehensive clinically validated whole genome test that includes structural variation, short tandem repeats, and large and small chromosomal abnormalities from a single base to the whole chromosome.
The Clinical Genomics Medical or Laboratory Director provides leadership to a team of highly motivated and skilled geneticists and genetic counselors interpreting whole genome sequence results and liaises between customers and technical support, product development, sales and bioinformatics, payer reimbursement and clinical coordination teams. In this role you will report to the chief director of clinical genomics. This position is full-time or part-time, onsite in Framingham, MA or remote.
- Review and approve clinical case reports using whole genome sequencing and other related methodologies.
- Provide onsite, telephone or electronic consultation as needed, ensuring that consultation is available to the laboratory’s clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions, which falls under the regulatory role of clinical consultant.
- Ensure testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic, and post-analytic phases of testing, and are appropriate for the patient population.
- Review all test methodologies and ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method.
- Ensure that reporting personnel are performing the test methods as required for accurate and reliable data and results.
- Ensure that prior to testing patients’ specimens, all personnel have the appropriate education and experience, and receive the appropriate training for the type and complexity of testing offered and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.
- Identify training needs and ensure that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.
- Ensure that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical, and post-analytical phases of testing to ensure they are competent and maintain their competency to process specimens, perform test procedures, and report results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills.
- Specify, in writing, the responsibilities of all laboratory personnel that identifies which test a person is authorized to perform and whether supervision is required. Also, include when supervisor or director review is required prior to reporting out a patient result.
- Relate and function effectively with applicable accrediting and regulatory agencies, appropriate administrative officials, the healthcare community, and the patient population served, and providers of formal agreements, when required.
- Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
- Ability to properly evaluate a wide variety of complex data from diverse laboratory, medical, and research sources and ability to integrate this information to provide a comprehensive, clinically relevant test report.
- Attention to detail in writing complex test reports and correspondence with internal and external clients.
- Speak effectively before groups of customers or employees of an organization.
- Solve complex problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Hold an MD and/or PhD in a chemical, physical, biological, or clinical laboratory science from an accredited institution and be certified and continue to be certified by the American Board of Medical Genetics and Genomics (ABMGG).
At least 2 years’ experience working in a clinical diagnostic genetic lab using NGS technology and ACMG variant curation.
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