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Associate Director, Pharmacometrics





East Hanover, New Jersey, United States

Job Description 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. Pharmacometrics 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.

The Associate Director, Pharmacometrics drives the pharmacometrics strategy for (early/full) clinical programs in multiple indications or a disease area. In this role, you will be a strong individual contributors with a broad and deep knowledge of modeling methodologies able to take on complex projects and provide strategic support on key drug development decisions. You will mentor and supervise execution of the pharmacometrics strategy in those programs when working with junior pharmacometricians. When given responsibilities to manage a project portfolio at the disease area or indication level, they are required to set the strategic role for pharmacometrics with a sound knowledge of the drug and disease biology and build strong collaborative relationships with key stakeholders.

What you’ll be doing: Your responsibilities include, but are not limited to:
• Provide global strategic pharmacometrics leadership for (early/full) clinical development programs of medium to high complexity, based on relevant technical and disease area knowledge.
• Represent the early/late Global Project Teams internally and externally as the pharmacometrics expert, including in regulatory interactions..
• Be a strong voice for pharmacometrics and decision and governance boards on model informed drug development.
• Leads the pharmacometrics evaluation of competing program/trial/analysis strategies assuring robust clinical development planning and execution.
• Be a strong mentor for junior pharmacometricians and help in training activities
• Define and drive pharmacometrics contributions to regulatory/submission strategy and related documents (e.g. briefing books, summaries of clinical pharmacology/efficacy/safety, responses to Health Authority questions).
• Represent PMX on all pharmacometrics aspects of the programs at global regulatory hearings/advisory committee meetings and other global regulatory interfaces.
• Drive and coordinate the synthesis and integration of pharmacometrics information to support transition of drug development milestones / decision boards. Identifies alternative strategic options to mitigate risk on (early/full) clinical programs.
• Ensure that the Analytics team (biometrician, data management, database programming, programming, medical and scientific writing) are aligned on the pharmacometrics strategy, execution and delivery of assigned projects.
• May manage portfolio at disease area/therapeutic area/indication level to support integration of pharmacometrics and relevant (target, compound, disease) knowledge in the planning and execution of robust development programs and strategies, under the supervision of the PMX Development Unit leader