Associate Clinical Development Director, Neuroscience
Novartis
Associate Director, Patient Centred Outcomes
GSK
full-time
Posted on:
Location Type: Hybrid
Location: London • 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
About the role
- Apply technical expertise to plan and support evidence development strategies for Patient Reported Outcomes (PRO)/Clinical Outcome Assessment (COA)-related endpoints.
- 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.
Requirements
- 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.
Benefits
- competitive salary
- annual bonus based on company performance
- healthcare and wellbeing programmes
- pension plan membership
- shares and savings programme
- hybrid working model
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
COA developmentPRO developmentclinical trial planningstatistical methodsdata analysisvalidation of PRO instrumentsevidence development strategiesimplementation of COAsinterpretation of clinical dataproject management
Soft skills
cross-functional collaborationcommunicationstrategic planningproblem-solvinginterpersonal skillsorganizational skillscritical thinkingattention to detailleadershipadaptability
