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Associate Director, Pharmacometrics


Executive Director


East Hanover, New Jersey, United States

The Pharmacometrics community at Novartis comprises a group of about 80 quantitative scientists supporting a portfolio of more than 80 clinical development projects in 10 therapeutic areas every day. Quantitative sciences are a critical part of bringing these new medicines to patients. Pharmacometric Scientists bring innovative modeling and simulation skills to every aspect of clinical drug development over a wide range of disease areas and drug modalities. We are dedicated to creating a collaborative and supportive culture where teamwork and learning is emphasized and innovative problem solving is encouraged. Come and join an industry leader where you will have the opportunity to grow and contribute as a quantitative drug development scientist in early- and late-stage projects.<br><br>The Associate Director, Pharmacometrics drives the pharmacometric strategy for (early/full) clinical programs in multiple indications or a disease area. In this role, you will perform or supervise execution of the pharmacometrics strategy in those programs with focus on implementing model-informed drug development (MIDD) approaches. You may manage a portfolio of projects at the disease area or indication level. You will set the strategy for addressing pharmacometric issues in regulatory submissions and directly influences drug development decisions with internal and external partners.<br><br>What you’ll be doing: Your responsibilities include, but are not limited to:<br>• Lead and drive PMX contributions to integrate relevant technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies.<br>• Lead and optimize the provision of pharmacometric contributions to regulatory/submission strategy and related documents: (e.g. briefing books, summaries of clinical pharmacology/efficacy/safety, and responses to Health Authority questions). <br>• Represent the Global Project Teams internally and externally, including interactions with Health Authorities and external key opinion leaders, as the recognized Novartis pharmacometrics expert within the Development Unit (or equivalent). Represent PMX at global regulatory hearings/advisory committee meetings and other global regulatory interactions.<br>• Represent PMX in due-diligence teams to evaluate in-licensing opportunities.<br><br>This position will be located at the East Hanover, NJ site and will not have the ability to be located remotely. This position will require 0% travel as defined by the business (domestic and/ or international).<br><br>[#video#{#400,300#}#/video#]