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Senior Scientist Position - Global Clinical Pharmacology (Oncology) Janssen R&D

From: Ouellet, Daniele [JRDUS] <douelle2>
Date: Fri, 15 Dec 2017 13:41:28 +0000

Dear NMusers,

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is rec=
ruiting a Senior Scientist Global Clinical Pharmacology to be located in Sp=
ring House, PA. Please apply at the following link:

The Senior Scientist Global Clinical Pharmacology (GCP) role is to apply an=
d promote GCP knowledge, including pharmacokinetics/pharmacodynamics analys=
es and principles of model-based drug development in the programs for all s=
tages of drug development ranging from pre-New Molecular Entity (NME) decla=
ration through Post-Marketing support, in collaboration with various stakeh=
olders, QS-Project Matrix teams, GCP and PM Leaders. With oversight, the TA=
 Scientist GCP can also execute the day-to-day operations for the clinical =
pharmacology aspects of the assigned programs.
The Senior Scientist, GCP can directly impact the operational results, as t=
hey are focused on investigation and characterization of how drugs interact=
 with biological systems or diseases so they can be used safely and effecti=
vely, and with the appropriate pharmaceutical formulation. As a Senior Scie=
ntist, main responsibilities include:

  * 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. With assistance fr=
om senior members, the TA Scientist GCP will translate quantitative knowled=
ge into strategic opportunities with key stake holders to drive development=
 along the model-based drug development principles
  * Assist GCP and PM Leaders with modeling and simulation activities in =
drug development programs. Perform and/or liaise for modeling and simulatio=
n analysis of preclinical-clinical data, translational PK/PD data, up to fi=
rst-in-human (FIH) and if applicable beyond FIH (dose/exposure-response ana=
lyses to guide dose regimen from pre-proof of concept (POC) and POC studies=
  * Assist GCP and PM Leaders with the execution of scientifically robust=
 and efficient clinical pharmacology strategies for NME and/or development =
  * Carries out functional responsibilities in accordance to applicable S=
OPs, regulatory requirements and Johnson & Johnson Credo principles
The ideal candidate will have:

  * Ph.D. in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical =
Engineering, or relevant Biological Sciences with a minimum of 2 years of r=
elevant experience OR PharmD in these fields with a minimum of 3 years of r=
elevant experience is required
  * Understanding of PK, PD, PK/PD, and Translational Medicine is require=
  * Modeling experience is required (e.g., NONMEM)
  * Ability to interpret PK and PKPD results and prepare presentations to=
 illustrate findings accurately is required
  * Understanding of overall process of drug development and the overall =
pharmaceutical R&D process is required
  * Has established a level of expertise and scientific reputation throug=
h publications and/or presentations is preferred
  * Drug development experience in Oncology (preferred) or other Therapeu=
tic Areas and the ability to handle contributions to multiple clinical phar=
macology programs, simultaneously is preferred
  * Demonstrated understanding of model based drug development (MBDD), bi=
opharmaceutics classification system (BCS), and biostatistics principles an=
d tools (e.g., NONMEM, Winnonlin, Gastroplus, Simcyp) and demonstrated abil=
ity to apply these tools to enable rational and efficient drug development =
is preferred
Daniele Ouellet, PhD
Senior Director, Global Clinical Pharmacology

Received on Fri Dec 15 2017 - 08:41:28 EST

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