Senior COA Scientist

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Oversee COA study projects from initiation to completion, ensuring the development and establishment of fitness-for-purpose COAs, which include PROs, ClinROs, PerfOs, and ObsROs.

• Manage COA research initiatives and collaborate with external third parties to guarantee timely project execution with a focus on quality and compliance.

• Assist in the formulation of disease-state and product-specific COA strategies in partnership with functional and cross-functional teams.

• Implement COA strategies alongside functional and cross-functional teams.

• Facilitate the integration of COA into early clinical development plans.

• Prepare regulatory documents under the guidance of the lead COA scientist.

• Design and conduct research to support the development of COA strategies.

• Develop and implement qualitative and psychometric analysis strategies.

• Contribute to clinical trial development, which includes protocols, statistical analysis plans, study reports, briefing books, and related documentation.

• Identify evidence gaps necessary for the effective use of COAs.

• Design and perform research aimed at developing or modifying COA instruments.

• Provide consultation on COA regulatory strategy.

• Create publications for peer-reviewed journals and scientific conferences.

• Compile scientific materials for patients and caregivers for distribution and transparency.

• Collaborate with project management teams to execute planned tasks.

• Communicate project progress clearly to team members.

• Ensure that appropriate measures and metrics are established.

• Monitor the external landscape and define future needs and priorities.

⛳️ Requirements

• Master’s degree or PhD in psychology, psychometrics, biostatistics, health outcomes, or a related field.

• At least 5 years of experience in COA development, validation, and/or application in clinical research (pharma, biotech, or CRO environment).

• Profound understanding of the regulatory landscape, particularly knowledge of FDA Patient Focused Drug Development guidance and other regulatory guidelines/evidentiary standards for COA (PROs, ObsROs, ClinROs, PerfOs) label claims.

• Proven technical expertise and practical scientific contributions in COA development and strategy.

• Direct experience in designing and executing patient-centered qualitative and quantitative research across various therapeutic areas.

• Exceptional written and verbal communication skills with the ability to summarize complex data effectively.

• Strong organizational capabilities and the ability to manage multiple projects autonomously.

• Relevant drug development and/or commercialization experience within the pharmaceutical sector, with a solid understanding of patient, regulator, and payer requirements.

• Significant experience in developing and implementing strategies to apply scientific methods related to measuring, assessing, and translating the patient experience across multiple disease areas.

• Employment with ICON is contingent upon possessing the legal right to work in the country where the role is based.

🏝️ Benefits

• Competitive base salary and performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Learning and development opportunities through structured training and career pathways.