Senior PRO/COA Strategy Consultant
About The Position
The Senior PRO/COA Strategy Consultant provides specialized patient-centered measurement expertise to support a growing portfolio of development programs and broader asset evidence strategies. The role supports early-stage programs that need foundational decisions on concepts of interest, measurement strategies, instrument selection, and endpoint planning before study designs are finalized. The consultant supplements internal capacity and provides timely, technically rigorous PRO/COA support across early-stage, cross-functional, and co-development activities. Program-specific confidential information will be shared as appropriate after applicable contracting and confidentiality requirements are completed. The assignment is expected to be strategic and scientific rather than primarily administrative or project-management focused. The final mix of assignments and priorities will be confirmed with the selected resource. The role is listed as remote and contract.
Requirements
- Advanced degree in a relevant field such as outcomes research, psychometrics, epidemiology, psychology, public health, or a related discipline.
- Approximately 8 or more years of relevant PRO/COA experience in pharmaceutical, biotechnology, consulting, or regulatory settings.
- Demonstrated experience developing PRO/COA strategies for clinical development programs, preferably including early development.
- Strong knowledge of patient-focused drug development, instrument selection, content validity, psychometric evidence, meaningful-change interpretation, and endpoint positioning.
- Experience reviewing clinical protocols, statistical analysis plans, and regulatory or evidence-planning documents.
- Ability to synthesize complex evidence and communicate clear recommendations to cross-functional stakeholders.
- Demonstrated ability to work independently, manage competing priorities, and operate effectively in a matrixed and co-development environment.
Nice To Haves
- Experience in immunology, dermatology, gastroenterology, or neurology.
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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What This Job Offers
Career Level
Senior
