Novartis-Senior Principal Pharmacometric Scientist (USA)

Novartis - Senior Principal Pharmacometric Scientist Position 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 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 understand the translational feasibility of new modalities of treatments in humans. The group is focused on delivering strategic and well-timed modeling input at key decision points along the development path. Members of the group are expected to be technically capable modelers and are encouraged to develop strategically as scientific partners and stakeholders that help inform drug development process for novel small molecules, biologics and cell & gene therapies. The Senior Principal Pharmacometric Scientist role has responsibility in planning, execution and delivery of modeling and simulation strategy on assigned projects within (pre/early/full) clinical development. S/he is responsible for the discussion and implementation of pharmacometric methodologies that optimally address the research and development objectives on the assigned projects. S/he provides pharmacometric support for regulatory submissions, and contributes to drug development decisions with internal and external partners. In this role, the associate 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. 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. Candidates should have requisite expertise in quantitative pharmacology, strong hands-on modeling and simulation skills, and demonstrated impact on drug development through quantitative approaches. Rich hands-on experience with NONMEM, Monolix, SPLUS, R, Matlab and/or other modeling and simulation software is required. Experience with mechanistic PK/PD and/or system pharmacology modeling is desired. The candidate must have excellent communication and interpersonal skills and the ability to work independently and effectively on interdepartmental project teams. Requirements: A Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent Ph.D. / MD) Fluent in English (Oral and written) required 5+ years industry experience required. 2+ years in applying model based methods in pre-clinical and clinical drug development. Good interpersonal and communication skills (verbal and writing) bridging scientific and business needs - integrating quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence. Expert knowledge and evidence of hands-on experience in the application of pharmacometrics methods to drug development. Scientific skills demonstrated in facilitating the (pre/early/full-) clinical development strategy. Clinical, pharmacological and therapeutic knowledge of at least one disease area preferred. Please apply through these links https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?jobId=2356875&PartnerId=13617&SiteId=5260 https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?jobId=2356235&PartnerId=13617&SiteId=5260 Ramprasad "Prasad" Ramakrishna Pharmacometrics Novartis Institutes for BioMedical Research, Inc., 45 Sidney Street, Cambridge, MA 02139, USA [email protected]<mailto:[email protected]> http://www.novartis.com/