•Master’s degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research or a closely related discipline
•Experience in a related role
•Project management experience
•PhD in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research or a closely related discipline
•Experience in pharmaceuticals, particularly in drug development, so as to understand drug development process, with demonstrated experience in clinical trial planning and execution
•Experienced with PRO/COA requirements for regulatory and HTA/reimbursement agencies including understanding of the FDA Patient Reported Outcomes Guidance
•Experience with managing PRO development and validation projects. Understanding of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of PRO data.
•Understanding of the evolving use of PRO research concepts to the development and evolving recommendations about clinical outcomes assessments
•Demonstrated communication skills, with stakeholder engagement from operations through executive levels
You will apply specialized technical expertise in support of an asset and/or disease area regarding the implementation of the Patient Reported Outcomes (PRO) [ Clinical Outcome Assessment (COA)) strategy, and the development, application and analysis of PRO/COA that will support registration, reimbursement and differentiation of GSK assets in development.
•Develop global COA endpoint strategic plans in collaboration with Early Development Teams (EDTs), Integrated Evidence Teams (IETs), Value Evidence Teams (VETs) and Clinical Sub-teams (CST) to assure alignment with product franchise goals;
•Responsible for implementation of PRO)/ clinical outcomes assessment strategies for assets in development, assuring alignment with clinical, health outcomes and commercial strategies and overall clinical development plan
•Coordinate and lead the development, validation, analysis, interpretation and utilization of instruments aimed at measuring COAs in the context of clinical trials and/or observational studies
•Ensure PROs are implemented appropriately in clinical trials, including writing relevant portions of the clinical trial protocols, training investigative site personnel on PRO principles and appropriate administration of PROs in the clinical trials
•Collaborate with clinical and statistical teams to ensure that COAs are appropriate analyzed and described in statistical analysis plans, study reports and publications
•Prepare relevant sections of documentation and communication and questions for regulatory agency meetings, support and/or participate in meetings at regulatory agencies, and provide robust evidence in support of submission activities
•Prepare abstracts and manuscripts presenting PRO results from clinical and PRO development and validation studies, aligned with publication strategy
•Responsible for maintaining awareness of scientific, regulatory, and market access developments within his/her areas of expertise across GSK functional areas, both in terms of new methodology and new activities to establish communication with key outcomes research opinion leaders;
•With PCO team, develop and provide training on COA-related topics to other departments, as needed;
•Keep up-to-date with methodologies and guidelines (including those from Regulatory Authorities) and communicate findings to VEO and functional groups as needed.
When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.
- Requisition ID: WD135438