US-NJ, Associate Director Pharmcometrics 214436BR-MZ
Associate Director Pharmcometrics
Global Drug Development
Global Develop NPH
East Hanover, NJ
Research & Development
The Associate Director Pharmacometric Scientist role involves leading at a global level the planning, execution and delivery of modeling and simulation strategy for multiple indications and/or a disease area (or equivalent) within (pre/early/full) clinical development
Will be responsible for the design and implementation of pharmacometric methodologies that optimally address the research and development objectives on the assigned projects. Will set the strategy for addressing pharmacometric support for regulatory submissions, and directly influences 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. 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 mentoring skills to help less experienced associates and 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.
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) English 5-10 years industry experience required. 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. Has experience working within clinical teams and contributing to (pre/early/full-) clinical development strategy with good strategic understanding for applying quantitative analysis at the appropriate time. Strong clinical, pharmacological and therapeutic knowledge of at least one disease area preferred. Has established track record of publications/presentations in pharmacometrics. Experience in contributing to scientific improvement/change initiatives. Excellent interpersonal and communication skills (verbal and writing) bridgin
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