Senior PRO/COA Strategy Consultant

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

📋 Description

• Develop and sustain the 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 fit-for-purpose PRO/COA evidence-generation studies from inception to completion, encompassing study design, protocol development, vendor management, scientific interpretation, and dissemination of results.

• Create or enhance conceptual models and prioritize key concepts of interest.

• Evaluate existing PRO/COA instruments to determine their fitness for purpose and identify any evidence gaps.

• Aid in the development of endpoint strategies and planning for COA evidence generation.

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

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

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

• Assist in vendor engagement and oversight for specific COA evidence-generation activities, as required.

• Operate in a strategic and scientific capacity rather than focusing predominantly 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.

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

• Vendors may suggest candidates with alternative experience profiles if the candidate can distinctly demonstrate the necessary expertise.

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

• Comprehensive 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 convey 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 desirable but not mandatory.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Collaborative and inclusive work environment.

• Flexible work arrangements.