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ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are seeking an experienced Clinical Pharmacology professional to support protocol development and pharmacokinetic/pharmacodynamic (PK/PD) analysis across Phase I–IV clinical trials as PK Scientist. This role involves protocol writing, non-compartmental analysis (NCA), and clinical pharmacology reporting while collaborating with cross-functional teams within a regulated clinical development environment.
Job Responsibility:
Author and coordinate development of clinical pharmacology trial protocols and ensure timely review, approval, and issuance
Perform preliminary, interim, and final PK, PD, and PK/PD analyses using non-compartmental methods
Develop the Clinical Pharmacology Analysis Plan (CPAP) and generate data handling logbooks prior to final NCA
Create tables, listings, and figures and contribute to drafting clinical pharmacology sections of Clinical Study Reports (CSRs)
Conduct QC review of protocols, analyses, datasets, and all deliverables while ensuring compliance with SOPs, ICH-GCP, and regulatory requirements
Requirements:
Bachelor’s degree or higher in a scientific discipline (or equivalent experience) with strong written and verbal communication skills
1+ years of relevant experience in clinical pharmacology, including exposure to clinical study protocols and regulatory requirements
Working knowledge of data analyses software packages
Hands-on experience with Phoenix WinNonlin and working knowledge of R for PK/PD analysis (Experience with R is an advantage)
Basic knowledge of noncompartmental PK analysis and statistical principles
Understanding of clinical trial data structures and experience collaborating with Data Management, Biostatistics, and CRO partners
What we offer:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others