Senior PRO/COA Strategy Consultant

TransPerfect

. Develop and maintain the PRO/COA components of asset evidence strategies in partnership with asset leads.

Posted 10/16/2026contractRemote • United States, United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and maintaining PRO/COA strategies, with a strong focus on patient-focused drug development and evidence generation. Capable of synthesizing complex evidence and providing clear recommendations to cross-functional teams.

Highest-signal resume keywords

PRO/COA Strategy DevelopmentPatient-Focused Drug DevelopmentClinical Protocol ReviewStatistical Analysis PlansEvidence Generation Planning

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Outcomes ResearchPsychometricsEpidemiologyClinical Development ProgramsInstrument SelectionContent ValidityPsychometric EvidenceMeaningful-Change InterpretationEndpoint PositioningEvidence Gap Assessment

Soft Skills

Independent WorkCross-Functional CommunicationPriority ManagementMatrixed Environment Adaptability

Certifications & Qualifications

Advanced Degree in Relevant Field

Industry Keywords

PharmaceuticalBiotechnologyConsultingRegulatory SettingsImmunologyDermatologyGastroenterologyNeurology

About the role

Key responsibilities & impact

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 GHEVO asset lead.
Support vendor engagement and oversight for discrete COA evidence-generation activities, as needed.
Work in a strategic and scientific capacity rather than primarily administrative or project-management focused.

Requirements

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.
Vendors may propose candidates with a different experience profile if the candidate clearly demonstrates the required expertise.
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.