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Investigator III / Snr Investigator I, PBPK/PD modeling, PK Sciences at NIBR

From: Mirjam Trame <mirjam.trame>
Date: Tue, 15 Jan 2019 19:41:47 -0500

*Position Title: Investigator III / Snr Investigator I, PBPK/PD modeling,
PK Sciences*

*Job Description:*

NIBR (Novartis Institutes for BioMedical Research is the innovation engine
of Novartis, focusing on powerful new technologies that have the potential
to help produce therapeutic breakthroughs for patients. NIBR includes about
6000 associates across 7 locations worldwide.

Translational Medicine (TM) is the clinical research arm of NIBR, and
includes about 1000 associates globally. TM plays a pivotal role in
bringing innovative medicines to patients, by building on research advances
to develop new therapies, and bridging drug discovery and clinical

PK Sciences (PKS) partners across both NIBR and the Global Drug Development
organizations to advance the scientific knowledge of pharmacokinetics,
metabolism and clinical pharmacology.

The Modeling & Simulation group within PK Sciences is looking for an
Investigator III / Senior Investigator I, to develop and apply
translational PK-PD and PBPK modeling along with data analysis techniques
to facilitate drug discovery, development, and translational research
across disease areas.

You will be familiar with developing PBPK models that are combined with
PD/QSP models to mechanistically predict clinical doses for compounds
transitioning from discovery to development. The candidate’s core
responsibilities also include PBPK modeling to integrate in vitro and in
vivo data for drug-drug interaction and special population predictions. The
candidate is interested in developing biopharmaceutic PBPK absorption
models to understand the interrelationships of physico-chemical properties
of the drug, the dosage form, and the route of administration on the rate
and extent of systemic availability.

The role requires a deep ADME/DMPK knowledge and/ or detailed
biopharmaceutics knowledge, experience with industry standard PBPK modeling
packages (such as GastroPlus or Simcyp), interdisciplinary thinking and
great attention to detail. The applicant will work in a dynamic and
multidisciplinary environment to build and verify quality
translational/biopharmaceutical PBPK models.

*Key responsibilities:*

*1. *Expert modeler to provide translational modeling support for global
drug discovery and development projects

*2. *Perform translational PBPK/PD analyses, assess clinical potential
of DDI with PBPK models as well as apply biopharmaceutic PBPK modeling to
support formulation changes.

*3. *Integrate PK/ PD data, ADME and DDI findings

*4. *Ability to interpret and communicated modeling results and
potential impact to project teams

*5. *Prepare summary documents for use in regulatory submission and
ability to respond independently to HA questions.

*Minimum requirements:*

· PhD in pharmacometrics/pharmacology/physiology, biomedical/
pharmaceutical sciences, or related sciences.

· A thorough understanding of the biology, pharmacology, mecha=
of action, efficacy biomarker and DMPK properties to build mechanism-based
mathematical models

· Experience with modeling tools such as Phoenix, R, Monolix,
Simcyp, GastroPlus, etc. and 5-10 years relevant industry experience

· Extensive experience in applying PBPK modeling.

· Experience in authoring regulatory documents, knowledge of g=
regulatory requirements and guidances

· Broad knowledge of drug discovery and development, e.g., on
topics of drug delivery, formulation, ADME, DDI, etc.

· Excellent written and oral communication skills

927 million. That’s how many lives our products touched in 2017. An=
d while
we’re proud of that, in this world of digital and technological
transformation, we must also ask ourselves this: how can we continue to
improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative
people like you are empowered to ask new questions, make bolder decisions
and take smarter risks. We are Novartis.

Join us and help reimagine medicine.

Please go to the following link for more information and to apply


*Mirjam N. Trame, Pharm.D., Ph.D.*

Associate Director Pharmacometrics,

Precision Medicine

Phone: +1 (617) 252 2004 (ext 42004)

Cell: +1 (617) 599 8386


*Novartis Pharma AG*

45 Sidney Street

Cambridge, MA 02139

Received on Tue Jan 15 2019 - 19:41:47 EST

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