Director of Clinical Pharmacology and Quantitative Pharmacology

Tasks

• Conduct exposure response modeling
• Contribute to pre IND IND IMPD packages
• Develop CPQP plans and analysis strategies
• Drive QSP scenario planning
• Execute PBPK modeling
• Lead CP sections of protocols
• Lead and develop scientists
• Lead clinical pharmacology strategy
• Optimize dosing during and after proof of concept
• Own clinical pharmacology posology delivery
• Perform population PK PD analyses
• Prepare PK PD protocol and report sections
• Provide integrated input across research toxicology immunogenicity
• Recommend first in human starting dose
• Shape late stage trial design
• Support regulatory meetings with FDA and EMA

Perks/Benefits

• Flexible working schedule
• In-person collaboration

Skills/Tech-stack

Allometric Scaling | Exposure-response | Monolix | Nonmem | PBPK | PD analysis | PK/PD Analysis | Phoenix | Physiologically Based Modeling | Population PK | Population PK PD Analysis | Population PK/PD | Population pharmacodynamics | Population pharmacokinetics | QSP | SimCYP