Senior PRO/COA Strategy Consultant

TransPerfect

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

Posted 10/16/2026contractRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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

Highest-signal resume keywords

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Outcomes ResearchPsychometricsEpidemiologyClinical DevelopmentInstrument SelectionContent ValidityPsychometric EvidenceEndpoint PositioningEvidence Gap IdentificationConceptual Model Development

Soft Skills

Independent WorkCross-Functional CommunicationPriority ManagementStakeholder EngagementMatrixed Environment Adaptability

Certifications & Qualifications

Advanced Degree in Relevant Field

Industry Keywords

PharmaceuticalBiotechnologyConsultingRegulatoryImmunologyDermatologyGastroenterologyNeurology

About the role

Key responsibilities & impact

Develop and maintain PRO/COA components of asset evidence strategies 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
Design studies, develop protocols, oversee vendors, interpret findings scientifically, and disseminate results
Develop or refine conceptual models and identify and prioritize concepts of interest
Assess PRO/COA instruments for fitness for purpose and identify evidence gaps
Support endpoint strategy development and COA evidence-generation planning
Review and provide input on protocols, endpoint sections, statistical analysis plans, and related study documents
Prepare recommendations, decision-support materials, and documentation for cross-functional review
Participate as the PRO/COA subject matter expert in internal and partner-facing working sessions
Support vendor engagement and oversight for discrete COA evidence-generation activities as needed
Work in a strategic and scientific capacity rather than primarily performing administrative or project-management duties

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
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
Confidentiality and contracting requirements must be completed before receiving program-specific confidential information

Benefits

Comp & perks

No benefits specified in the posting