Associate Director, Patient Centred Outcomes

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OverviewWe 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 Life at GSK | GSK.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) and Clinical Outcome Assessment (COA) endpoints across GSK’s portfolio. The PCO team works to develop integrated evidence plans that support patient-centric understanding of our drug development, with opportunities across Therapeutic areas including Respiratory, Immunology and Inflammation, Infectious Diseases, Vaccines and Oncology. The team collaborates with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, Commercial and Patient Focused Development, and engages with external initiatives to define and interpret patient-centric endpoints.The PCO team maintains a focus on patient-centric outcomes across the portfolio, ensuring each clinical program has a well-characterized PRO/COA strategy defined early in development with plans to develop supporting evidence.Ready to shape the future of healthcare?In this role you will…Define and oversee the execution of strategies for the development and implementation of PRO/COAs across GSK’s portfolio.Guide development, validation, analysis, interpretation, and utilization of PRO/COA instruments in clinical trials and observational studies.Collaborate cross-functionally (clinical operations, biostatistics, regulatory) to communicate the value of patient-centric endpoints early and ensure PRO/COAs are implemented and analyzed appropriately in trials and described in statistical analysis plans, study reports and publications.Support communications with regulatory bodies by developing questions related to PRO/COA endpoint strategy and identifying evidence needed for meetings to support patient-centric endpoint strategies.Support broader publication strategy by planning and contributing to external publications presenting PRO/COA results from trials and validation studies.Engage in ongoing learning to adopt evolving methodologies and guidelines from regulatory authorities and share findings with cross-functional groups as needed.Why you?Basic Qualifications and Skills:Bachelor’s degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology, Pharmacy, Public Health or a related discipline.Considerable experience in a COA development and implementation role in a pharmaceutical environment, with experience in clinical trial planning and execution.Clear understanding of FDA COA/PFDD Guidance and knowledge of regulatory and reimbursement decision making related to COA data in drug and vaccine development.Experience managing COA development and validation projects.Strong background in statistical methods for evaluating COA endpoints.Understanding of evolving COA methods and regulatory environment.Preferred Qualifications & SkillsNote: The following skills are preferred but not required; please apply if you do not have them:Master’s degree in a relevant subject with strong problem-solving and analytical skills.Ability to thrive in a fast-paced, innovative environment with flexibility and initiative.Strong listening, collaboration, leadership, and stakeholder management skills.Clear and concise communication.Closing DateClosing Date for Applications – 19th October 2025 (COB).Additional informationGSK is an Equal Opportunity Employer. This ensures all qualified applicants receive equal consideration for employment regardless of race, color, religion, sex, parental status, national origin, age, disability, or genetic information. We support an agile working culture and accommodate adjustments as needed; contact details are available upon request. #J-18808-Ljbffr
Location:
Stevenage, England, United Kingdom
Job Type:
FullTime

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