Associate Director, Patient Outcomes

Job Summary

To support innovative drug development, the full-time remote Associate Director, Patient Outcomes will manage endpoint strategies and measurement science support, ensuring patient-centered and digital measures are effectively integrated into clinical trials across various therapeutic areas.

Key Responsibilities

• Develop and implement scientifically rigorous Clinical Outcome Assessment (COA) strategies aligned with regulatory requirements and evidence-generation goals
• Collaborate cross-functionally to ensure accurate implementation of COA strategies in clinical trials and contribute to regulatory submissions
• Support the integration of digital measures and technology-enabled endpoints into COA strategies while staying current on emerging tools and methodologies

Required Qualifications

• Bachelor's degree in psychometrics, health outcomes research, epidemiology, biostatistics, public health, or a related discipline
• 5+ years of relevant experience in pharmaceutical, biotechnology, or digital health settings, with expertise in COAs or patient-centered outcomes
• Working knowledge of FDA PFDD Guidances and relevant international regulatory frameworks
• Experience in developing, validating, or implementing COA instruments or digital measures in clinical trials
• Familiarity with statistical methods for evaluating COA and digital endpoints, including psychometric analysis