Develop, validate, and apply pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling) to support drug development programs.
Conduct and present pharmacokinetic modelling and simulation (M&S) analysis to management and technical teams for project advancement.
Predict human pharmacokinetics based on in-silico, in-vitro, and in-vivo data, including dose scaling and profile prediction.
Conduct IVIVE and IVIVC.
Work closely with cross-functional teams including preclinical, clinical, and regulatory teams to guide decision-making and project direction.
Utilize software tools such as WinNonlin, R, SAS, Matlab, Monolix, GastroPlus, Simcyp, PK-Sim, and other similar platforms for M&S.
Develop and optimize models for bioequivalence studies, sample size determination, and regulatory submissions.
Support regulatory filings for New Chemical Entities (NCE), 505(b)(2), and generic products.
Engage in all aspects of drug development, with a focus on predicting human pharmacokinetic and pharmacodynamic behaviour under different dosing regimens.
Use advanced statistical approaches for bioequivalence analysis and large-scale data handling.
Collaborate in the development and refinement of methodologies and approaches in PK modelling.
Ensure clear communication of findings through presentations and written reports using Microsoft Excel, Word, and PowerPoint.
Employment Type: Full Time, Permanent
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