Scientist, Patient Reported Outcomes (PRO)
- Bachelor's degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research or a closely related discipline
- Demonstrated strong project management experience
- Master's degree or 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
- Strong communication skills, with stakeholder engagement from operations through executive levels
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.
- Under direction of PRO Director, 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
- Under direction of PRO Director, 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
- Under direction of PRO Director, 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 PRO 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.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
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