Senior Principal Scientist/Associate Director Clinical PBPK (Dual Level Posting)

Expert PBPK modeler to provide translational modeling support for global drug discovery and development projects. Perform translational PBPK analyses to predict clinical drug exposure in specific populations, assess potential for DDI, understand clinical impact of disease on drug exposure, as well as apply biopharmaceutic PBPK modeling to support formulation changes and achieve clinical biowaivers. Integrate PK/ PD data, ADME and DDI findings. Ability to interpret and communicate modeling results and potential impact to project teams. Prepare summary documents for use in regulatory submissions and ability to respond independently to health authority questions.

The Modeling & Simulation group within PK Sciences is looking for a Principal Scientist to Associate Director level modeler, to develop and apply translational physiologically based pharmacokinetic (PBPK) modeling along with data analysis techniques to facilitate drug discovery, development, and translational research across disease areas. Importantly, the candidate has experience with regulatory submissions and in successful regulatory interactions. The candidate’s core responsibilities will include PBPK modeling to integrate in vitro and in vivo data for drug-drug interaction (DDI) assessments, impact of biopharmaceutics properties on absorption, and pharmacokinetic (PK) predictions in humans as well as in specific populations (e.g. disease, organ impairment, pediatrics). The ultimate goal of this work is to be on the forefront of applying PBPK models to inform the safe administration of our drug candidates in the clinic, to optimize clinical trial designs, and waive clinical trials, ultimately, to get our medicines to patients faster.

• PhD in pharmaceutical sciences or related discipline with experience in ADME/DMPK sciences, biopharmaceutics, and modeling and simulation.

• At least 5+ years in pharmaceutical industry including demonstrated knowledge and experience with PBPK modeling.

• Hands on experience with PBPK modeling tools such as PK-Sim, Simcyp, or GastroPlus is required.

• Experience with modeling software such as Monolix, R, Phoenix, or Nonmem is desired.

• Experience in authoring regulatory documents, knowledge of global regulatory requirements and guidance.

• Broad knowledge of drug discovery and development, e.g., pharmacokinetics, drug delivery, formulation, ADME, DDI, etc.