Senior PRO/COA Strategy Consultant

This is a fully remote position, open to applicants in United States, +4 more locations.

📋 Description

• Collaborate with asset leads to develop and maintain the PRO/COA components of asset evidence strategies.

• Perform comprehensive reviews focused on disease, patient experience, competition, regulations, and endpoint landscapes.

• Oversee fit-for-purpose PRO/COA evidence-generation studies from inception to conclusion, which includes study design, protocol development, vendor management, scientific interpretation, and dissemination of results.

• Create or enhance conceptual models while identifying and prioritizing relevant concepts of interest.

• Evaluate existing PRO/COA instruments for their suitability and identify any evidence gaps.

• Assist in the development of endpoint strategies and COA evidence-generation planning.

• Provide technical reviews and insights for protocols, endpoint sections, statistical analysis plans, and associated study documentation.

• Prepare succinct recommendations, decision-support materials, and documentation for cross-functional evaluation.

• Act as the PRO/COA subject matter expert during internal and partner-facing working sessions, in coordination with the asset lead.

• Facilitate vendor engagement and oversight for specific COA evidence-generation initiatives, as necessary.

⛳️ Requirements

• An advanced degree in a relevant discipline such as outcomes research, psychometrics, epidemiology, psychology, public health, or a related field.

• Around 8 or more years of pertinent PRO/COA experience within pharmaceutical, biotechnology, consulting, or regulatory environments.

• Proven experience in developing PRO/COA strategies for clinical development programs, ideally including early development stages.

• In-depth knowledge of patient-focused drug development, instrument selection, content validity, psychometric evidence, meaningful change interpretation, and endpoint positioning.

• Experience in reviewing clinical protocols, statistical analysis plans, and regulatory or evidence-planning documentation.

• Capacity to synthesize complex evidence and effectively communicate clear recommendations to cross-functional stakeholders.

• Demonstrated ability to work autonomously, manage competing priorities, and function effectively in a matrixed and co-development setting.

• Experience in immunology, dermatology, gastroenterology, or neurology is preferred but not mandatory.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and continuing education.

• Flexible working hours and a supportive work environment.

• Generous paid time off and holiday schedule.