Job description preview
From AstraZeneca’s original posting
Typical Accountabilities · Ensure the optimal application of clinical pharmacokinetics (PK), pharmacodynamics (PD), and modelling & simulation (M&S) in clinical development programs, including: 1. Design and conduct clinical studies including CP studies (dosing rationales, sampling schemes, etc.) 2. Data analyses (e.g., M&S) to elucidate dose-exposure-response relationships, and result interpretations 3. Play a central role in justifying dose recommendations for Asian population by using quantitative approaches 4. Promote M&S approaches in clinical development programs whenever applicable 5. When applicable, develop mathematical and statistical models to understand disease mechanism, its progression, and PK/PD; conduct meta-analyses as appropriate to maximize data use. 6. Preparation and defence of regulatory submissions, as well as regulatory interactions such as end of phase consultation meetings, query response, etc. · Interact with internal and external stakeholders for assigned projects · Literature research and knowledge sharing; publish clinical pharmacology-related research articles and reviews in peer-reviewed journals, when applicable · Train junior CP staff Education,…
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