This position is responsible for supporting clinical development of vaccine programs by qualifying clinical assays fit-for-use for assessment of immune responses in phase 1/2 clinical trials, and also for the conduct of cell-based assays on samples acquired as part of early-stage clinical trials.
The primary responsibility of the role is to create and maintain the informatics structure for capturing experimental data generated for RD experiments, automate analysis of such data sets across a diverse set of projects, provide QC assessments of the data and pre-defined analysis.
The successful candidate will have a background and expertise in inflammation, immunology, and/or immuno-oncology as it relates to lymphocyte biology, especially T cell biology (NK/Macrophages cell biology is preferred).
In this role, you will be responsible for the oversight of a number of projects primarily within the ORU PDM group providing scientific leadership and strategic direction to assigned projects from idea to POC.
Support all scientific aspects of clinical trial(s) and program level activities as assigned, providing scientific expertise to study protocols, case report forms, statistical analysis plans, interpretation of results, clinical study reports, graphical displays.
In this role, you will be responsible for working closely with peers, Clinical Affairs management, R&D, Data Management, and Marketing groups to design study-related documentation, protocols and study reports for various types of diabetes-related studies. Must possess technical writing, communication, and monitoring skills, including organizational skills.
The focus will be on cellular and animal models of fatty liver disease, inflammation and fibrosis, including signaling pathways, transcriptional regulation and disease pathway modification with Intercepts therapeutic approaches.