Designs and implements program-specific late development biomarker/translational plans, responsible for aiding in creation of clinical protocols, SAPs, SOWs, lab manual, and interfacing with CRO for execution of services, in conjunction with Biospecimen Operations and Procurement. Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation partnering with Translational Sciences colleagues when applicable. Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs.