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Zealand Pharma is expanding its Modelling & Simulation capabilities and is seeking a Director-level, hands-on Translational PK/PD modeller to drive MIDD across preclinical and early clinical programs. The position focuses on developing and applying empirical, semi-mechanistic, and mechanistic PK/PD models to inform lead candidate selection, biomarker strategy, and early clinical dose selection.
Job Responsibility:
Lead and execute hands-on mechanistic and translational PK/PD modelling and simulation to enable MIDD from preclinical through early clinical development
Develop and apply mechanistic and semi-mechanistic models (e.g., TMDD, PBPK, systems PK/PD, and disease models) to support dose selection, study design, and development strategy
Translate preclinical PK/PD and biomarker data into quantitative predictions for first-in-human and early clinical studies, supporting go/no-go and design decisions
Drive and manage collaborations with external partners (including CROs), ensuring high scientific quality and timely delivery of modelling outputs
Contribute to internal governance, external collaborations, and MIDD-relevant documentation, supporting regulatory strategy where needed
Requirements:
PhD in pharmacometrics, PK/PD modelling, PBPK, quantitative systems pharmacology, or a related quantitative discipline, with extensive relevant industry experience
Strong track record in translational and mechanistic PK/PD modelling impacting early clinical development decisions
Extensive hands-on experience with MATLAB/SimBiology, PBPK software, or similar tools for mechanistic modelling
Experience with R and population PK/PD tools (e.g., NONMEM, Phoenix) and applying population approaches alongside mechanistic models
Solid understanding of MIDD concepts, including quantitative translation, biomarker integration, and model-based dose selection and study design
Experience writing and/or contributing to regulatory documents/submissions
ability to communicate assumptions, limitations, and impact clearly to senior stakeholders