*Position Title: Investigator III / Snr Investigator I, PBPK/PD modeling, PK Sciences*
*Job Description:* NIBR (Novartis Institutes for BioMedical Research is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6000 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. PK Sciences (PKS) partners across both NIBR and the Global Drug Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology. The Modeling & Simulation group within PK Sciences is looking for an Investigator III / Senior Investigator I, to develop and apply translational PK-PD and PBPK modeling along with data analysis techniques to facilitate drug discovery, development, and translational research across disease areas. You will be familiar with developing PBPK models that are combined with PD/QSP models to mechanistically predict clinical doses for compounds transitioning from discovery to development. The candidate’s core responsibilities also include PBPK modeling to integrate in vitro and in vivo data for drug-drug interaction and special population predictions. The candidate is interested in developing biopharmaceutic PBPK absorption models to understand the interrelationships of physico-chemical properties of the drug, the dosage form, and the route of administration on the rate and extent of systemic availability. The role requires a deep ADME/DMPK knowledge and/ or detailed biopharmaceutics knowledge, experience with industry standard PBPK modeling packages (such as GastroPlus or Simcyp), interdisciplinary thinking and great attention to detail. The applicant will work in a dynamic and multidisciplinary environment to build and verify quality translational/biopharmaceutical PBPK models. *Key responsibilities:* *1. *Expert modeler to provide translational modeling support for global drug discovery and development projects *2. *Perform translational PBPK/PD analyses, assess clinical potential of DDI with PBPK models as well as apply biopharmaceutic PBPK modeling to support formulation changes. *3. *Integrate PK/ PD data, ADME and DDI findings *4. *Ability to interpret and communicated modeling results and potential impact to project teams *5. *Prepare summary documents for use in regulatory submission and ability to respond independently to HA questions. *Minimum requirements:* · PhD in pharmacometrics/pharmacology/physiology, biomedical/ pharmaceutical sciences, or related sciences. · A thorough understanding of the biology, pharmacology, mechanism of action, efficacy biomarker and DMPK properties to build mechanism-based mathematical models · Experience with modeling tools such as Phoenix, R, Monolix, Simcyp, GastroPlus, etc. and 5-10 years relevant industry experience · Extensive experience in applying PBPK modeling. · Experience in authoring regulatory documents, knowledge of global regulatory requirements and guidances · Broad knowledge of drug discovery and development, e.g., on topics of drug delivery, formulation, ADME, DDI, etc. · Excellent written and oral communication skills *WHY CONSIDER NOVARTIS?* 927 million. That’s how many lives our products touched in 2017. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks. We are Novartis. Join us and help reimagine medicine. Please go to the following link for more information and to apply https://www.novartis.com/careers/career-search/job-details/257170BR -- *Mirjam N. Trame, Pharm.D., Ph.D.* Associate Director Pharmacometrics, Precision Medicine Phone: +1 (617) 252 2004 (ext 42004) Cell: +1 (617) 599 8386 mirjam.tr...@novartis.com *Novartis Pharma AG* 45 Sidney Street Cambridge, MA 02139 USA
