Novartis is committed to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life. The Pharmaceuticals division is at the forefront of development and commercialization in oncology, primary care and specialty medicines. The pharmacometric modeling group (PMX) at Novartis is a key partner in supporting clinical development by applying modeling and simulation to inform drug development. This group supports all clinical development programs in general medicines through the application of model based approaches to characterize dose-exposure-response relationships, disease progression, drug delivery, as well as understanding the translational feasibility of new modalities of treatments in humans. The group is very focused on delivering strategic and well-timed modeling input at key decision points along the development path. Members of the group are not only expected to be technically capable modelers, but are also encouraged to develop strategically as scientific partners and stakeholders that help inform drug development process for novel small molecules, biologics and cell & gene therapies.
Senior Principal Scientist Pharmacometric Scientist role involves responsibility in planning, execution and delivery of modeling and simulation strategy on assigned projects within (pre/early/full) clinical development. Is responsible for the discussion and implementation of pharmacometric methodologies that optimally address the research and development objectives on the assigned projects. Provides pharmacometric support for regulatory submissions, and contributes to drug development decisions with internal and external partners. In this role, the candidate is expected to identify the relevant development questions that would benefit from model-based methods and develop modeling plans to deliver meaningful and timely results clearly to development teams. Appropriate support will be provided by senior mentors to develop the ability to handle complex scientific and team interactions. The candidate must have excellent communication and interpersonal skills and the ability to work independently and effectively on interdepartmental project teams. They are also expected to have good collaborative skills with other quantitative disciplines including biostatistics. The scope of modeling activities include population PK/PD models, drug-disease models, clinical trial simulations, literature meta-analyses, and other state of the art modeling and simulation techniques. Key technical responsibilities are to organize, execute, and report modeling and simulation independently, as well as to present work at cross-functional teams, departmental meetings, senior management review committees, regulatory interactions, and scientific conferences.
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The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent Ph.D. / MD) required
2-5 years of Industry experience is required or equivalent experience with problem solving in other settings (academic/regulatory authority).
Candidates should have requisite expertise in quantitative pharmacology, strong hands-on modeling and simulation skills, and demonstrated impact on drug development through quantitative approaches. Experience with mechanistic PK/PD and/or system pharmacology modeling is preferred.
Rich hands-on experience with NONMEM, Monolix, SPLUS, R, Matlab and/or other modeling and simulation software is required.
Strong clinical, pharmacological and therapeutic knowledge of at least one disease area preferred.
Has established track record of publications/presentations in pharmacometrics.
Excellent interpersonal and communication skills (verbal and writing) in presenting quantitative analysis and results to non-modeling scientists and clinicians.
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