The Clinical Quality Specialist will own data quality generated in Loyal’s pre-clinical and clinical studies. They are responsible for implementing quality assurance and quality control processes to ensure studies are conducted and data are generated, documented, and reported in compliance with applicable protocols, GLP, GCP, and regulatory requirements. This role will participate in quality initiatives, collaborating with cross functional teams.
As the Senior Manager, Biologics Analytical Research & Development, plan to collaboratively work with the CMC organization to define strategies to solve complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines. Support activities related to clinical drug substance and drug product stability studies at various contract laboratories. Provide technology development, strategic leadership, and technical expertise in protein biologics method development, optimization, and qualification/validation.
This role will design, conduct, and deliver studies via scientific approaches to support product pre-launch, launch and post-launch for Intuitive’s technologies with a focus on health equity, social and structural determinants of health and humanistic value. This researcher will collaborate with teams across multiple business units and other GAVE centers of excellence to conduct research and manage collaboration with co-authors to produce scientifically rigorous evidence in support of the Quintuple Aim.
The Senior Biostatistician provides statistical input into Phase I - IV clinical trial development, performs the analysis of clinical trial data, and provides statistical input into the reporting of clinical trial results. The Senior Biostatistician can work independently and function as a lead statistician on clinical trials. Responsibilities include providing statistical input into protocol and case report form (CRF) development.
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.
As CEO of XtRNA Bio, you will provide strategic and operational leadership to advance our pioneering tRNA therapeutic platform from research toward clinical development. Key responsibilities include: Lead the company’s overall strategy, growth, and fundraising, securing seed and Series A investment. This role calls for a leader who can unite scientific insight, strategic execution, and purpose-driven leadership.
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.