We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.Discover more about our company wide benefits and life at GSK on our webpage.Associate Director, Patient Centered OutcomesAs an Associate Director of Patient-Centered Outcomes (PCO) you will apply technical expertise to plan and support evidence development strategies for Patient Reported Outcomes (PRO)/Clinical Outcome Assessment (COA)-related endpoints across GSK’s portfolio.GSK’s PCO team plays an integral role in the development of integrated evidence plans to ensure that strong PRO/COA strategies support a patient-centric understanding of our drug development. The team has educational backgrounds across a range of PRO/COA disciplines and experience in pharmaceutical, regulatory, and academic settings.The PCO team maintains a sharp focus on the value of patient-centric outcomes across the entire GSK portfolio. 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.Ready to shape the future of healthcare?In this role you will…Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across GSK’s 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 to ensure the value of patient-centric endpoints is communicated early and clearly and that PRO/COAs are implemented and analysed appropriately in clinical trials.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 GSK’s patient-centric endpoint strategies.Support broader publication strategy by planning for and contributing to external publications which present PRO/COA-related results from clinical trials and/or PRO/COA development and validation studies.Pursue ongoing learning to understand and adopt evolving methodologies and guidelines and communicate findings to cross functional groups as needed.Why you?Basic Qualifications & Skills:Bachelor’s degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology, Pharmacy, Public Health or a closely related discipline.Considerable experience in a related role with COA development and implementation in a pharmaceutical environment, particularly in drug and vaccine development, with demonstrated experience in clinical trial planning and execution.Clear understanding of the FDA COA/PFDD Guidance and understanding of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of COA data in drug and vaccine development.Experience with managing COA development and validation projects.Strong background in statistical methods for the evaluation of COA endpoints.Understanding of the evolving methods and regulatory environment with respect to COAs.Preferred Qualifications & Skills:Master’s degree in a relevant subject with excellent problem-solving, analytical, and critical thinking skills.Ability to thrive in a fast paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.Outstanding listening and collaborative team working and leadership skills, as the role involves interface with a wide range of stakeholders internally and externally.Clear and concise communication.GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law. #J-18808-Ljbffr