Principal Research Pharmacist
On-site · Groningen, Groningen, The Netherlands
Job Summary
Lead development and oversight of clinical research protocols for phase I/IIa studies involving investigational medicinal products (IMP) within a GMP/GCP framework. Provide pharmacological expertise on dosing, administration, pharmacokinetics/pharmacodynamics, and safety to support clinical decision-making. Oversee management of IMP accountability, storage, and regulatory compliance; supervise GMP processes at the manufacturing site and the release of IMP by a Qualified Person. Collaborate with cross-functional teams and external partners to develop formulations and drive successful study execution. Guide and mentor pharmacy teams, promote best practices in clinical research, and contribute to continuous improvement of study processes. Requires BIG-registered pharmacist status and Qualified Person (QP) designation, with advanced training/certification in clinical research, clinical pharmacology, or GMP as a plus.
Required Qualifications
- BIG-registratie als apotheker
- Qualified Person (QP)
- Geavanceerde training of certificering in klinisch onderzoek, klinische farmacologie of GMP is a pré
- Ruime ervaring als apotheker in klinisch onderzoek, farmaceutische ontwikkeling of een verwant vakgebied
- Diepgaand begrip van klinische studieontwerpen en regelgevende vereisten
- Uitgebreide kennis van farmacologie, farmacokinetiek en farmacodynamiek
- Vermogen om expertise toe te passen op protocollen en geneesmiddelveiligheidsbeoordelingen
- Sterke analytische en probleemoplossende vaardigheden
- Uitstekende communicatieve en leidinggevende vaardigheden
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
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