US-NJ, Principal Pharmacometrician, Oncology Pharmacometrics 228432BR-MZ
Principal Pharmacometrician, Oncology Pharmacometrics
Global Drug Development
East Hanover, NJ
Research & Development
Provide population pharmacokinetic and -dynamic model building, interpretation of results, and consultancy to drug development teams to ensure that results of quantitative analyses are understood and built into drug development programs. Lead execution and delivery of pharmacometrics tasks on assigned projects within pre, early and full clinical development. Coordinate discussion and implementation of pharmacometric methodologies that optimally address research and development objectives. Define drug development strategies with regards to US regulations, in partnership with correspondents within Novartis and the FDA. Provide pharmacometric support (PK/PD, dose-finding), and proactively seek support and input from senior PMX colleagues and franchise leadership. Apply strong clinical, medical and pharmacological knowledge of diseases, molecular and metabolic pathways, drug effects on a cellular and molecular level, to develop mechanistic and empiric models to predict drug behavior, and safety & efficacy on adult and pediatric patients. Apply experience and expertise in pharmacometrics, quantitative pharmacology, and modeling and simulation, including methodological expertise and hands-on experience with NONMEM, Monolix, SPLUS, R, and Matlab. Utilize optimal design software such as PFIM in optimal sampling design for clinical trial planning. Work with cross-functional teams and bridge scientific and business needs. Train colleagues and Novartis stakeholders in NONMEM, Monolix, PFIM and R as required. Collaborate with R&D team members, pharmacometric franchise head and senior pharmacometric associates to negotiate and develop (pre/early/full) clinical trial objectives and pharmacometric deliverables. Collaborate with partners in (pre-/early/full) clinical development teams (Medical Scientific Expert/Global Program or Brand Medical Directors/Translational Medicine Experts and PMX Franchise head) to provide pharmacometric support for the quantitative evaluation of competing trial/analysis strategies assuring robust support to clinical development planning and execution and alignment with the clinical development profile and target product profile. Apply methodological expertise and experience in analysis of continuous and categorical data using non-linear mixed effect models. Write and execute modeling plans, and deliver reports of results in collaboration with pharmacometric franchise leadership. Contribute to pharmacometric scientific content of materials for internal decision boards/regulatory/submission documents: Briefing Books, decision criteria, trial design(s), responses to trial-specific Health Authority questions. Align the Quantitative team (biometrician, data management, database programming, programming, medical and scientific writing) on pharmacometric strategy and execution on assigned projects. Apply Systems Pharmacology methodology to influence drug development strategy and inform key opinions leader on best course of action. Assess and improve scientific and written quality of internal and external documents such as presentations and reports, for Novartis and as reviewer for peer-reviewed international journals. Participate in creation of international guidance to issue good practices in pharmacometrics, and teach hands-on and methodology to pharmacometricians and partners in areas such as clinical pharmacology and statistics. Deliver presentations to senior management, regulatory agencies and at scientific conferences as required.
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.
Candidate must have PhD or foreign equivalent degree in Pharmacology, Biostatistics, Public Health or directly related field, and minimum 2 years of strong working knowledge and experience in pharmacometrics and model-based methods in planning strategy and influencing key decision points in drug development, including: PK/PD and dose-finding modeling and computer simulation approaches; methodological expertise and experience in analysis of continuous and categorical data using non-linear mixed effect models; optimal sampling design for clinical trial planning using software such as PFIM; mechanistic and empiric models to predict drug behavior, and safety & efficacy on patients; applying strong clinical, medical and pharmacological knowledge of diseases, molecular and metabolic pathways, drug effects on a cellular and molecular level; with methodological expertise and hands-on experience with NONMEM, Monolix, R, and Matlab. Must have demonstrated success in collaboration with cross-functional teams, and interaction and communication to bridge scientific and business needs; and experience in presentation to colleagues, senior management and scientific conferences, and writing for publication.
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