NOVARTIS Associate Director Pharmacometrics Scientist Position
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Job Description:
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. PMX 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.
The Associate Director Pharmacometrics Scientist is the global lead for the
planning, execution and delivery of pharmacometric strategy for multiple
indications and/or a disease area (or equivalent) within (pre/early/full)
clinical development. S/he is responsible for the design and implementation of
pharmacometric model based methodologies that optimize the drug development
program for each indication or disease area. S/he sets the strategy for
addressing pharmacometric issues in regulatory submissions and directly
influences drug development decisions with internal and external partners.
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 Associate Director is expected to mentor junior associates in specific
areas of modeling, communication with teams and developing pharmacometric
strategy. The Associate Director should be able to effectively communicate the
relevance and value provided by pharmacometric modeling to key decision points
in drug development.
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.