Bristol Myers Squibb
Designs and implements program-specific late development biomarker/translational plans, aiding in the creation of clinical protocols, SAPs, SOWs, and lab manuals. Interfaces with CRO for execution of services, in conjunction with Biospecimen Operations and Procurement. Determines appropriate assays and vendors for clinical biomarkers, manages outsourcing of biomarker assay development and validation, and manages clinical biomarker data delivery and analysis. Prepares and delivers internal and external translational/biomarker presentations and supports regulatory submissions and interactions as needed.