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]>
www.novartis.com<http://www.novartis.com/>



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