About This Role
This role involves designing and implementing PBPK models for small molecules and biotherapeutics to support discovery and development programs. The scientist will apply these models to new chemical entities to understand tissue distribution, predict absorption and pharmacokinetics, and evaluate drug-drug interactions. The position is suitable for a professional with strong PBPK modeling experience in pharmaceutical sciences or a related field.
Responsibilities
- Develop the PBPK framework for preclinical species and humans in Simcyp, Gastroplus, Matlab, or other relevant software
- Apply the models to new chemical entities for understanding tissue distribution to inform drug-target coverage and safety margins, predicting absorption and PK, and evaluating the impact of drug-drug interactions
- Predict PK in special populations (e.g., hepatic or renal impairment patients, pediatrics, pregnant population, diseased population, etc.)
- Develop novel PBPK models to answer mechanistic questions (e.g., understanding complex clearance mechanisms, impact of biopharmaceutical properties on oral absorption characteristics, translation across species)
- Perform in silico ADME support as an enabler for PBPK model parameterization
- Maintain input and output records and record workflow documentation
- Collaborate with multi-functional project teams and functional group colleagues to identify data requirements for model development, and strategies for model application and use
- Communicate recommendations from modeling analyses to influence decisions in drug discovery and development
Requirements
- PhD degree with 5+ years relevant experience, or MS with 6+ years relevant experience, or BS with 8+ years relevant experience in Pharmaceutical Sciences, Drug Metabolism and Pharmacokinetics, Pharmacology, or another relevant field
- Strong understanding of the concepts of, and prior experience in PBPK modeling
- Strong training and understanding of the concepts of drug metabolism and pharmacokinetics of diverse modalities (e.g., small molecules, biotherapeutics), biochemical aspects of drug metabolism enzymes and transporters, and various in vitro assays conducted to assess DDI potential
- Knowledge and understanding of biopharmaceutics (e.g., solubility, dissolution, permeability, formulation, and absorption mechanisms) with application to prediction of drug absorption
- Proficient in one or more of the following modeling and simulation software: Simcyp, Gastroplus, PK-Sim, Matlab, or another relevant software
- Exceptional interpersonal, verbal communication, and writing skills
- Good organizational and planning skills
- Proven record of accomplishment of teamwork, adaptability, innovation, initiative, and integrity
- Strong quantitative, analytical, and problem-solving skills
