Senior PRO/COA Strategy Consultant

Responsibilities

• Develop and maintain the PRO/COA components of asset evidence strategies in partnership with asset leads.
• Conduct disease, patient-experience, competitive, regulatory, and endpoint landscape reviews.
• Lead fit-for-purpose PRO/COA evidence-generation studies from concept through completion, including study design, protocol development, vendor oversight, scientific interpretation, and dissemination of findings
• Develop or refine conceptual models and identify and prioritize concepts of interest.
• Assess existing PRO/COA instruments for fitness for purpose and identify evidence gaps.
• Support endpoint strategy development and COA evidence-generation planning.
• Provide technical review and input for protocols, endpoint sections, statistical analysis plans, and related study documents.
• Prepare clear recommendations, decision-support materials, and documentation for cross-functional review.
• Participate as the PRO/COA subject matter expert in relevant internal and partner-facing working sessions, coordinated with the asset lead.
• Support vendor engagement and oversight for discrete COA evidence-generation activities, as needed.

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