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Lead, coach, and develop Bioanalytical Study Management scientists as one integrated team, including goal setting, performance enablement, development planning, engagement, role clarity, and accountability for delivery; Set and drive the strategy for
You will lead the development and execution of global regulatory strategies in close collaboration with co-development partners and internal and external stakeholders. Acting as regulatory lead for complex projects, you will draw upon
Extrapolation (where appropriate), dose selection, trial design, PIP development and ongoing evaluation of data as generated. Transform PBPK and QSP analyses into actionable insights and communicate these findings effectively to project teams and
Responsible for leading non‑clinical and early clinical pharmacology strategy across drug development programs. Provides expertise in PK/PD, modeling & simulation, and Model‑Informed Drug Development (MIDD) to support dose selection, study design, and