Senior PRO/COA Strategy Consultant

The Senior PRO/COA Strategy Consultant supports a growing portfolio of development programs by contributing specialized patient-centered measurement expertise to broader asset evidence strategies. Several programs are in early development, where foundational decisions regarding concepts of interest, measurement strategy, instrument selection, and endpoint planning need to be established before study designs are finalized.

This person will supplement internal capacity and help ensure timely, technically rigorous PRO/COA support across early-stage, cross-functional, and co-development activities. Program-specific and confidential information will be shared only as appropriate following completion of applicable contracting and confidentiality requirements.

What You’ll Do

• 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.

The final assignment mix and priorities will be confirmed with the selected resource. The role is expected to be strategic and scientific, rather than primarily administrative or project-management focused.

What You’ll Need

• 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.

• Experience in immunology, dermatology, gastroenterology, or neurology is desirable but not required.

Originally posted on Himalayas