Senior COA Scientist

ICON plc

. Lead COA study projects from end to end and ensure development and establishment of fitness-for-purpose COAs, including PROs, ClinROs, PerfOs, and ObsROs .

Posted 9/17/2026full-timeRemote • Pennsylvania • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in COA development, validation, and application within clinical research, with a strong focus on regulatory compliance and patient experience measurement. Proficient in executing qualitative and quantitative research strategies across therapeutic areas while effectively managing multiple projects.

Highest-signal resume keywords

COA DevelopmentRegulatory ComplianceQualitative ResearchQuantitative ResearchClinical Trial Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PsychometricsBiostatisticsStatistical AnalysisPatient Reported Outcomes (PROs)Clinical ResearchResearch DesignPsychometric AnalysisData SummarizationEvidence Gap IdentificationCOA Instrument Development

Soft Skills

Excellent CommunicationStrong Organizational SkillsProject ManagementTeam CollaborationTransparency in Communication

Certifications & Qualifications

Master’s DegreePhD

Industry Keywords

FDA GuidancePatient Focused Drug DevelopmentPharmaceutical IndustryBiotechCRO Setting

About the role

Key responsibilities & impact

Lead COA study projects from end to end and ensure development and establishment of fitness-for-purpose COAs, including PROs, ClinROs, PerfOs, and ObsROs
Manage COA research projects and engage with external third parties to ensure timely project execution with quality and compliance
Support development of disease-state and product-specific COA strategies with functional and cross-functional teams
Execute COA strategies with functional and cross-functional teams
Support integration of COA into early clinical development plans
Draft regulatory documents under direction of the lead COA scientist
Design and execute research to inform COA strategy development
Develop and execute qualitative and psychometric analysis strategies
Support clinical trial development, including protocols, statistical analysis plans, study reports, briefing books, and related documents
Identify evidence gaps needed to support fit-for-purpose use of COAs
Design and execute research to develop or modify COA instruments
Consult on COA regulatory strategy
Develop publications for peer-reviewed journals and scientific meetings
Package scientific materials for patients and caregivers for dissemination and disclosure
Partner with project management teams to deliver planned work
Communicate project status transparently to team members
Ensure appropriate measures and metrics are in place
Monitor the external environment and define future needs and priorities

Requirements

What you’ll need

Master’s degree or PhD in psychology, psychometrics, biostatistics, health outcomes, or related field
Minimum 5 years of experience in COA development, validation, and/or application in clinical research (pharma, biotech, or CRO setting)
Deep working understanding of the regulatory environment with particular knowledge of FDA Patient Focused Drug Development guidance and other regulatory guidances/evidentiary standards for COA (PROs, ObsROs, ClinROs, PerfOs) label claims
Demonstrated technical expertise and hands-on scientific contributions in COA development and strategy
Direct experience designing and executing patient-focused qualitative and quantitative research across multiple therapeutic areas
Excellent written and verbal communication skills with ability to summarize complex data
Strong organizational skills and ability to manage multiple projects independently
Relevant drug development and/or commercialization experience within the pharmaceutical industry with strong knowledge of patient, regulator, and payer requirements
Significant demonstrated experience in developing and implementing strategies to apply scientific methods associated with the measurement, assessment and translation of the patient experience in multiple disease areas
Employment with ICON is contingent upon having the legal right to work in the country where the role is based

Benefits

Comp & perks

Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways