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/