Patient Reported Outcomes / Clinical Outcomes Assessment Scientist
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
Apply Now
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
Apply Now