Senior COA Scientist

🔥 8 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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

• 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

• 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