Director, Head of Predictive Modelling & Biopharmaceutics

Job Description

ACCOUNTABILITIES:

• Provides strategic and operational leadership for the Predictive Modeling and Biopharmaceutics function within drug product development, ensuring capabilities, priorities, and deliverables align with portfolio and business objectives.
• Builds and develop a high performing predictive modeling and biopharmaceutics team which works across the whole Oral Drug Product Development organization to drive modelling excellence and execution
• Leads the development and implementation of predictive modeling and biopharmaceutics strategies to support formulation design, dosage form selection, and product performance evaluation across development stages.
• Ensures the effective application of modeling and simulation approaches to assess biopharmaceutics risks, including absorption, dissolution, bioavailability, and in vivo performance.
• Oversees the generation, interpretation, and integration of biopharmaceutics data to enable scientifically sound and timely development decisions.
• Provides scientific and organizational leadership in predictive sciences, including PBPK/PBBM, absorption modelling, IVIVC/IVIVR, and related methodologies, to strengthen development outcomes and decision quality.
• Partners with cross-functional stakeholders across formulation, analytical, clinical pharmacology, regulatory, and CMC disciplines to incorporate predictive and biopharmaceutics strategies into program plans.
• Directs the contribution of predictive modeling and biopharmaceutics expertise to regulatory strategies and submissions, ensuring scientific rigor and alignment with applicable regulatory