Role Responsibilities Develops and executes PCOA strategies to support therapeutic area/asset specific clinical development plans, global HV&E strategies, integrated evidence plans, and commercial strategies. Collaborates with cross-functional stakeholders to ensure PCOA strategies and deliverables are fit-for-purpose and aligned with program goals. Ensures PCOA strategies align with current regulatory and HTA guidance documents (e.g., FDA, EMA, JCA). Leads qualitative and quantitative evidence generation research to inform and support PCOA strategies. Provides technical expertise in implementation, analysis, interpretation, and communication of clinical outcome assessment (COA) data. Manages a global network of consultants and contract organizations to execute COA evidence generation deliverables (e.g., qualitative COA development evidence, psychometric analyses, COA qualification dossiers). Maintains awareness of new research methods, tools, and data sources to ensure study methods reflect the current state of science. Promotes the value of patient-centered outcome assessments through education and training. Basic Qualifications Advanced academic degree (e.g., MSc, MPH, PhD, DrPH, ScD, PharmD) in a relevant field such as public health, psychology, health economics, epidemiology, pharmacy administration, or other research-focused health outcomes. Minimum 5 years’ experience with PhD/DrPH/ScD/PharmD, or minimum 7 years’ experience with MSc/MPH in consulting, pharmaceutical industry, or academia in COA research or related health outcomes research. Advanced understanding of COA research methodology (qualitative and quantitative). Knowledge of regulatory guidance documents (FDA, EMA). Strong analytical and synthesis skills of qualitative and quantitative data demonstrated in scientific publications. Experience developing new or validating existing COA measures in multiple therapeutic areas or assets. Experience preparing regulatory briefing documents and COA dossiers to support COA-based labeling. Scientific rigor, autonomy, and initiative. Ability to work effectively in a fast-paced, cross-functional matrix environment and independently. Technical competency in systematic literature reviews and qualitative research. Technical competency in use of ePRO/eCOA and linguistic validation of COAs. Strong project management skills (multiple projects, budget planning, vendor management, competing deadlines, shifting priorities). Excellent interpersonal skills; ability to respond to internal/external customers and influence in a matrix environment. Excellent oral and written English communication skills. Preferred Qualifications Knowledge of basic elements of psychometric analysis. Experience leading PCOA strategy discussions during formal meetings with global regulatory agencies. Application Instructions Last Date to Apply for Job: April 21st, 2026. Additional Job Details Ability to travel domestically and internationally. Hybrid role requiring onsite 2 to 3 days per week. #J-18808-Ljbffr