Description
• The PCO team maintains a sharp focus on the value of patient-centric outcomes across the entire respiratory and immunology portfolio, vaccines and oncology.
• We want to ensure that each clinical program has a well-characterized, innovative PRO/COA strategy that is defined early in the development lifecycle and has clear plans to develop evidence that supports PRO/COA-related… endpoints.
• Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across our portfolio
• Guide the development, validation, analysis, interpretation, and utilization of PRO/COA instruments in the context of clinical trials and/or observational studies
• Work cross-functionally (e.g., clinical operations, biostats teams) to ensure the value of patient-centric endpoints is communicated clearly and that PRO/COAs are implemented and analyzed appropriately in clinical trials (and are accurately described in statistical analysis plans, study reports and publications)
• Support key communications with regulatory bodies by developing targeted questions related to the PRO/COA endpoint strategy and identifying the critical evidence needed for meetings to support patient-centric endpoint strategies
• Support broader publication strategy by planning for and contributing to external publications (e.g., scientific abstracts and peer-reviewed manuscripts) which present PRO-related results from clinical trials and/or PRO development and validation studies
• Maintain awareness of scientific and regulatory changes across our specialty and primary care drug development programs
• Pursue ongoing learning to understand and adopt evolving methodologies and guidelines (including those from regulatory authorities) and communicate findings to cross functional groups as needed.
Qualifications
• Bachelor’s degree
• Preferably Master’s degree, and relevant experience
