Senior COA Scientist

Senior COA Scientist

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior COA Scientist at ICON, you will design, implementing, and analyze outcomes research studies aimed at assessing the real-world effectiveness of healthcare interventions.

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* What You Will Do:

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* ** _Project Lead and Strategic Support (45%)_*
* + Lead COA study projects from end to end, and ensure the development and establishment of fitness-for-purpose COAs, including PROs, ClinROs, Perf Os, and ObsROs

+ Manage the COA research project and engage with external third parties to ensure timely project execution with quality and compliance

+ Support the development of disease-state and product-specific COA strategies in alignment with functional and cross-functional teams, under supervision by the Lilly lead COA scientist

+ Execute COA strategies directly with functional and cross-functional teams to drive impact

+ Support the integration of COA into early clinical development plans under supervision by the COA Lead

+ Draft regulatory documents under the direction of lead COA scientist

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** _Research and Disclosure Execution (50%)_*
* + Execute and ensure the effective execution of work plans resulting in the development of relevant, reliable, and timely evidence for patients, regulators, clinicians, caregivers, and payers including:

+ Design and execute research to inform COA strategy development

+ Develop and execute a qualitative and psychometric analysis strategy

+ Support clinical trial development for assigned programs, including relevant portions of protocols, statistical analysis plans, study reports, briefing books, and related documents

+ Identify gaps in available evidence needed to support fit-for-purpose use of COAs in a specified context

+ Design and execute research to develop or modify COA instruments for inclusion in assigned programs

+ Consult on COA regulatory strategy

+ Develop publications of early COA research for disclosure in peer-reviewed journals and at scientific meetings

+ Ensure effective packaging of information and scientific materials for patients and caregivers for dissemination and disclosure

+ Develop effective working partnership with project management teams which enable teams to deliver planned work

+ Ensure regular and transparent communication of project status to team members

+ Ensure that appropriate measures and metrics are in place.

** _External Engagement (5%)_*
* + Monitor and understand the external environment and use insight to define and articulate future needs and priorities.

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* Your Profile:

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* + 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, Perf Os) 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…