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.

What You Will Do:

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, PerfOs, 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
• •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.

Your Profile:

• •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.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• •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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here .

Are you a current ICON Employee? Please click here to apply