>500 Million real world patient records are used to help reimagine how integrated evidence generation will transform healthcare decision making. You will enable cross-functional teams (V&AT, GMAT, GPT) in becoming leaders in utilization and generation of RWE as part of integrated evidence in innovative and advanced ways. Focused on priority disease areas and gaps, responsible for the development of an impactful and scientifically robust Real World Evidence (RWE) strategy with a focus on prospective studies and retrospective clinically-oriented studies and innovative trial designs
Your responsibilities will include:
Ensure a broad understanding of the value of RWE to the product value demonstration both globally and locally. Lead and ensure innovative study designs with best-in-class integrated evidence planning and creation with GDD, to maximize value of key development projects, products, and businesses in key geographies. Lead a cross-functional Real World Evidence team, consisting of representatives from GMAT, V&AT, GPT, QS&E, CPO team, embedded within a franchise and being a liaison to team members of the RWE Evidence and Launch Excellence team. Utilize a decision matrix to determine with Medical Affairs / Patient Access / Safety / Product teams the most suitable source of RWD and RWE generation approach that meets prioritized evidence needs. Where secondary data is not available to generate fit-for-purpose evidence recommend the most appropriate prospective data collection study design and analysis that achieves the objectives. Provides input and supports to develop high quality functional and cross-functional plans (e.g. IDP, GMA plan, HEOR plan, Communication plans) Implement and ensure uniform excellence standards across franchises Lead innovation pilots that can support to overcome key challenges in drug development using RWD or enable to provide meaningful RWE in support of regulatory decision making (e.g. label changes, new indications).