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[NMusers] Global Clinical Pharmacology Positions at Janssen R&D

From: Ouellet, Daniele [JRDUS] <douelle2_at_its.jnj.com>
Date: Thu, 20 Oct 2016 14:07:02 +0000

Janssen Research & Development, L.L.C., a Johnson & Johnson company, has se=
veral openings in Global Clinical Pharmacology (GCP) at our East Coast US l=
ocations (Spring House, PA, Titusville, NJ, or Raritan, NJ). We are seekin=
g highly motivated individuals to join our group at Janssen at Scientist, S=
enior Scientist or Associate Director level. The individual is to apply and=
 promote GCP knowledge, including pharmacokinetics (PK) and PK/pharmacodyna=
mics (PD) analyses, translational modeling and principles of model-based dr=
ug development in the programs for all stages of drug development ranging f=
rom pre-New Molecular Entity (NME) declaration through Post-Marketing suppo=
rt, in collaboration with senior members of the group and various other sta=
keholders.

Main responsibilities include (based on experience):


  * Contribute to overall compound development via application of quantit=
ative methods to integrate knowledge of PK, PD, patient characteristics, di=
sease states, and drug-drug interactions to optimize dose selection, dosage=
 regimens and study designs throughout drug development. Translate quantita=
tive knowledge into strategic opportunities with key stake holders to drive=
 development along the model-based drug development principles.


  * Perform modeling and simulation activities in drug development progra=
ms. Perform and/or liaise for modeling and simulation analysis of preclinic=
al-clinical data, translational PK/PD data, up to first-in-human (FIH) and =
if applicable beyond FIH (dose/exposure-response analyses, formulation and =
drug-drug interaction characteristics to guide dose regimen from pre-proof =
of concept (POC) and POC studies).


* Develop protocol concepts for Clinical Pharmacology studies inclu=
ding drug-drug interaction studies, safety pharmacology studies and biophar=
maceutics studies; perform analysis and interpretation of data from the stu=
dies and presentation of results to the project teams. Provide PKPD guidanc=
e to Phase 2-3 studies.


An ideal candidate will have a doctoral degree (e.g., Ph.D.) in Pharmaceuti=
cs, Pharmacokinetics, Applied Mathematics, or Chemical and or Biomedical En=
gineering with keen interest in drug development, have an understanding of =
pharmacokinetics and pharmacodynamics principles, and have experience analy=
zing data describing biologic or PK/PD systems, preferably using a non-line=
ar mixed effects modeling approach. Experience with computation software ap=
plications such as SimCYP, Gastro-Plus, R, MATLAB, SAS, NONMEM or similar s=
oftware is desired.

A job posting will be available at the ACoP7 meeting in Bellevue; for furth=
er details on the position please contact Daniele Ouellet at douelle2_at_its.j=
nj.com<mailto:douelle2_at_its.jnj.com>.

Janssen Research & Development, LLC discovers and develops innovative medic=
al solutions to address important unmet medical needs in oncology, immunolo=
gy, neuroscience, infectious diseases and vaccines, and cardiovascular and =
metabolic diseases. Please visit http://www.JanssenRnD.com for more informa=
tion.




Received on Thu Oct 20 2016 - 10:07:02 EDT

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