State Licensed Patient Outcomes Director

Job Summary

Working remotely on a full-time basis, the State Licensed Patient Outcomes Director will develop and implement high-quality Clinical Outcome Assessment (COA) strategies, collaborating cross-functionally to ensure patient-centric endpoints are effectively integrated into clinical trials.

Key Responsibilities

• Develop and implement scientifically rigorous COA strategies aligned with regulatory requirements and evidence-generation goals
• Collaborate with cross-functional teams to ensure accurate implementation of COA strategies in clinical trials
• Support the integration of digital measures into COA strategies and stay updated on emerging tools and technologies

Required Qualifications

• Bachelor's degree in psychometrics, health outcomes research, epidemiology, biostatistics, or a related discipline
• 5+ years of relevant experience in pharmaceutical, biotechnology, or academic settings with expertise in COAs or related measurement science
• Working knowledge of FDA PFDD Guidances and international regulatory frameworks
• Experience in the development, validation, or implementation of COA instruments or digital measures in clinical trials
• Familiarity with statistical methods relevant to COA evaluation, including psychometric analysis and mixed-effects models