Senior Director, Patient Reported Outcomes
Core
Lead the development and execution of Patient-Reported Outcomes (PRO) strategies for clinical development programs to integrate patient-centered evidence into regulatory and market access objectives.
Role type
Senior Director, Patient-Reported Outcomes (PRO)
Builds
Clinical development programs for oncology medicines targeting RAS-addicted cancers
Domain
Oncology / Clinical Development / Health Outcomes Research
Required skills
PRO strategy development, instrument selection and validation, qualitative and quantitative PRO methodologies, regulatory guidance application, cross-functional collaboration, scientific communication
Preferred skills
Oncology clinical development experience, Phase 2/3 program support, external vendor and patient organization management, regulatory/HTA interaction experience
Technologies
PRO instruments, statistical analysis plans, regulatory documents
Responsibilities
Develop and lead PRO strategy for assigned clinical development programs; Recommend and support the selection, implementation, and interpretation of PRO measures; Partner with cross-functional teams to incorporate PRO objectives into study designs and protocols; Plan and oversee qualitative and quantitative research activities; Provide methodological guidance on endpoint definitions and benefit-risk assessment; Contribute PRO expertise to regulatory submissions and health technology assessment agencies; Support the analysis and dissemination of PRO evidence through reports and publications
Seniority
Senior Director, Individual Contributor with potential for people management