• Clinical Outcome Assessments (COA):
• Provide expertise in patient-reported outcomes (PRO), clinician-reported outcomes, and COA endpoint development.
• Lead and guide endpoint development strategies for clinical trials.
• Support regulatory interactions by ensuring compliance with current regulatory requirements for patient-reported outcomes.
  
  
• Clinical Trials & Study Support:
• Collaborate with clinical study teams throughout early to late-stage drug development.
• Conduct literature searches to inform COA endpoints.
• Participate in clinical trial protocol development and COA implementation.
• Lead non-interventional studies to validate COA measurement instruments.
• Interpret data and contribute to clinical study reports.
  
  
• Cross-Functional Collaboration & Leadership:
• Work with regulatory agencies and reimbursement teams (HTA - Health Technology Assessment).
• Integrate within multi-disciplinary teams including Value Evidence Teams and other strategic groups.
• Take ownership of assigned projects, ensuring proactivity and responsiveness in communication.

• Must-Have Experience:
• Industry experience in pharmaceutical or drug development (academic backgrounds alone are not sufficient).
• Strong knowledge of regulatory guidelines for patient-reported outcomes.
• Clinical trial experience is mandatory (observational study experience is a plus but not a substitute).
• Demonstrated ability to lead and contribute to COA endpoint development.
• Preferred Experience:
• Experience working in a COA group within a pharmaceutical company.
• Familiarity with non-interventional and real-world evidence studies.
• Prior collaboration with regulatory and reimbursement agencies.

Pay Range:
$60 - $70/hr.