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Clinical Science Professional
vor 1 Woche
About the Position
ITech Consult AG is seeking a highly skilled Clinical Science Enabler (CSE) to join our team in Basel. As a CSE, you will be responsible for planning, managing, and evaluating clinical pharmacology studies.
Main Responsibilities
- Oversee the overall planning and management of clinical pharmacology studies, ensuring compliance with regulatory requirements.
- Conduct data evaluation and reporting, providing strategic insights to stakeholders.
- Collaborate with internal groups to identify solutions for clinical study support and manage external solutions through trustful relationships.
- Utilize advanced data visualization tools to facilitate data-driven decision-making.
- Apply modeling techniques to support model-informed drug development (MIDD).
- Ensure regulatory compliance by integrating regulatory requirements into clinical studies and project workflows.
- Maintain up-to-date knowledge of regulatory guidelines and policies.
Requirements
- A degree in a relevant scientific discipline (e.g., MSc, PharmD, PhD) in pharmaceutical sciences, clinical pharmacology, or a related field.
- Minimum of 4+ years of experience in clinical pharmacology science, with a proven track record of being responsible for the scientific aspects of clinical pharmacology studies.
- Extensive expertise in the evaluation and interpretation of clinical pharmacology data, including pharmacokinetics (PK), pharmacodynamics (PD), biomarkers, and safety.
- Proficiency in Non-Compartmental Analysis (NCA) data analysis and interpretation and understanding of modeling principles, such as PBPK and popPK.
- Skilled in integrating quantitative and qualitative data to inform decision-making and providing strategic and scientific insights across multiple studies.
