Senior PRO/COA Strategy Consultant

This is a fully remote position, open to applicants in Florida, +2 more states.

📋 Description

• Develop and sustain PRO/COA components of asset evidence strategies in collaboration with asset leads.

• Perform reviews of disease, patient experience, competitive landscape, regulatory requirements, and endpoints.

• Oversee PRO/COA evidence-generation studies from initial concept to final completion, ensuring they are fit for purpose.

• Design studies, create protocols, manage vendors, interpret scientific findings, and disseminate results effectively.

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

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

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

• Review and provide feedback on protocols, endpoint sections, statistical analysis plans, and related documentation for studies.

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

• Act as the PRO/COA subject matter expert in both internal and partner-facing working sessions.

• Support vendor engagement and oversight for specific COA evidence-generation activities as required.

• Function strategically and scientifically rather than focusing primarily on administrative or project management tasks.

⛳️ Requirements

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

• Around 8 years or more of pertinent PRO/COA experience in 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 documents.

• Capability to synthesize complex evidence and articulate clear recommendations to cross-functional stakeholders.

• Proven ability to work independently, manage competing priorities, and function effectively within a matrixed and co-development environment.

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

• Confidentiality and contracting requirements must be fulfilled before access to program-specific confidential information is granted.

🏝️ Benefits

• No benefits specified in the posting.