Principal Scientist II to Senior Principal Scientist, Clinical PBPK Modeling & Simulation

Role Summary

Principal Scientist II to Senior Principal Scientist, Clinical PBPK Modeling & Simulation. Based in Cambridge, MA. Dual level posting for Principal Scientist II or Senior Principal Scientist level modeler to develop and apply translational physiologically based pharmacokinetic (PBPK) modeling and data analysis to support drug discovery, development, and translational research. Includes experience with regulatory submissions and interactions. Focus on PBPK modeling to integrate in vitro/in vivo data for DDI assessments, biopharmaceutics impact on absorption, and PK predictions in humans and specific populations. Aims to inform safe administration, optimize trial design, and accelerate patient access to medicines.

Responsibilities

• 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, and 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

Qualifications

• PhD in pharmaceutical sciences or related discipline with experience in ADME/DMPK sciences, biopharmaceutics, and modeling and simulation
• 3+ years in pharmaceutical industry including demonstrated knowledge and experience with PBPK modeling. To be considered at the Sr. Principal Scientist level, at least 6 years of industrial experience
• 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.

Skills

• Regulatory writing and regulatory submission readiness
• Translational modeling and cross-functional communication
• Data analysis and interpretation of PK/PD, ADME, DDI findings

Education

• PhD in pharmaceutical sciences or related discipline

Additional Requirements