Associate Director, Clinical Outcomes

Job Summary

To lead the development and execution of COA strategies for assigned clinical programs, the full-time Associate Director, Clinical Outcomes will apply qualitative and quantitative methods to support endpoint selection and regulatory submissions while working remotely.

Key responsibilities

• Identify and evaluate fit-for-purpose COAs for assigned programs, ensuring alignment with regulatory and value evidence needs
• Design and oversee the generation of COA evidence, contributing to regulatory dossiers and health authority responses
• Serve as the COA point of contact on clinical study teams, representing COA in cross-functional program governance and external forums

Required qualifications

• Bachelor's degree in outcomes research, health services research, epidemiology, psychology, public health, or a related field
• 7+ years of relevant experience in COA/PRO or patient-centered outcomes research, with at least 5 years specific to COA work
• Demonstrated experience in designing and executing COA evidence-generation projects independently
• Working knowledge of FDA/EMA patient-focused drug development guidances and their application to clinical development
• Comprehensive understanding of the pharmaceutical industry and regulatory requirements from a global perspective