PK Scientist
Icon Clinical PLC
Industria de Investigación Farmacéutica
Milano - Italien
Project Manager Junior / Técnico especialista
Experteer Overview
In this Senior PK Scientist role, you will support protocol development and PK/PD analyses across clinical trial phases. You will work within a cross‑functional, regulated development environment to contribute to CPAPs, analyze data, and draft clinical pharmacology sections of CSRs. Your work will emphasize non‑compartmental PK methods, data handling, and quality control to ensure regulatory compliance. The position offers exposure to global trials and a chance to shape pharmacology strategy in a leading CRO setting. You’ll operate at the intersection of science, data, and regulatory standards to drive robust clinical pharmacology outcomes.
Compensaciones / Beneficios
- annual leave entitlements
- health insurance offerings
- retirement planning
- Global Employee Assistance Programme
- life assurance
- flexible country-specific optional benefits
Responsabilidades
- Author and coordinate development of clinical pharmacology trial protocols and manage approval processes
- Perform PK, PD, and PK/PD analyses using non‑compartmental methods across study phases
- Develop the CPAP and data handling logbooks prior to final NCA
- Create tables, listings, and figures and contribute to drafting clinical pharmacology sections of CSRs
- QC review protocols, analyses, datasets, and deliverables to ensure SOP, ICH‑GCP, and regulatory compliance
Requisitos principales
- 4+ years of relevant clinical pharmacology experience
- Bachelor’s degree or higher in a scientific discipline
- Hands‑on PK & PD software knowledge, especially Phoenix WinNonlin; working knowledge of R for PK/PD (advantage)
- Excellent data‑handling skills and knowledge of database structures
- Experience with noncompartmental PK analysis and PK/PD analyses
- Strong written and verbal communication skills
Descripción del puesto
In this Senior PK Scientist role, you will support protocol development and PK/PD analyses across clinical trial phases. You will work withi…
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