As a Field Application Scientist at Cellanome, you will play a fundamental role in helping customers and collaborators solve problems and get the most out of the instrument outputs and workflow. In partnership with engineering colleagues, you will carry out trainings on Cellanome platform usage to ensure all potential end users gain experience. You will also support new product Introductions to ensure successful deployment of new and innovations of existing products in the field.
Reporting to the Shriners Children’s Vice President of Research, the Clinical Genomics Laboratory Director (CGLD) is responsible for establishing and maintaining a Clinical Laboratory Improvement Amendments/Certified Analytics Professional (CLIA/CAP) compliant high complexity laboratory operation with a focus on next generation sequencing (NGS). Initial priorities include development and implementation of a compliant end-to-end workflow and establish a comprehensive quality management system to ensure all clinical diagnostic and regulatory requirements are met.
The person in this position will provide support to the Global Epidemiology group in Clinical Sciences. This person will contribute to the design, execution and presentation of pharmacoepidemiologic studies, support characterization of descriptive epidemiology for diseases and indications, contribute to regulatory submissions and responses, and perform literature reviews.
This position reports into the Office of the Product Safety Team (PST) within the Clinical Sciences organization’s Global Strategic Operations. As an Epidemiology Study Operations Manager within the Office of the PST, you will support and partner with the Global Epidemiology organization to achieve its mission in managing the lifecycle of studies utilizing real world evidence and to ensure compliance with quality standards.
Responsible for the design and execution of our clinical studies, you will work closely with cross-functional teams, develop study protocols, analyze data, and generate clinical evidence to support regulatory submissions. This individual will collaborate closely with external stakeholders including key opinion leaders and Investigators, and provide support for clinical evidence discussions with regulatory agencies.