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[NMusers] Director/Pharmacometrician/Clinical Pharmacologist in Quantitative Clinical Development Group in PAREXEL – Home base option available

From: Iavarone, Laura <Laura.Iavarone_at_parexel.com>
Date: Mon, 11 Jun 2018 07:09:40 +0000

=================

PAREXEL’s Quantitative Clinical Development department provides expertise=
, across numerous therapeutic indications, in the strategic implementation =
of modeling & simulation services to drive drug development decision making=
. Our global team of experienced scientists offers unsurpassed expertise in=
 Clinical PK/PD, Pharmacometrics, and Model-Based Drug Development (MBDD) f=
rom Translational Sciences for First Time in Human (FTIH) through all Phase=
s of Drug Development to Marketed products.
Leverage your PK and PD expertise skills as a primary source of scientific =
support for the design, analysis, reporting, and presentation of sophistica=
ted PK/PD modeling and simulation initiatives, including population PK/PD a=
nalyses for all phases of development at PAREXEL.

We are looking for a motivated individual with an established track record =
in effectively applying clinical pharmacology principles and pharmacometric=
 methodologies to aid worldwide clients’ rational and informed decision m=
aking in drug development.

JOB DESCRIPTION

• Analyze clinical PK/PD data as a member of

multidisciplinary development program teams

• Conducts population PK, PK/PD M&S analyses

· Provide advice on the application of PK, PK/PD modeling and sim=
ulation to clients

· Attend regulatory agency interactions as a project clinical pha=
rmacometric representative

• Assist clinical teams study design PK/PD components in all phases=
 of clinical drug development such as first-in-human, POC, pediatric PK, bi=
oequivalence, biosimilar and drug-drug interaction studies

• Review of scientific documentation including Clinical

Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Report=
s

• Provide Quality Control (QC) for NCA and

NONMEM analysis and derived data generated by PK Analyst

• Author and contribute to scientific publications,
REQUIRED SKILLS AND EXPERIENCE
• Excellent knowledge of PK and PD principles
• Strong experience with the design and
implementation of Model-Based Drug Development strategies
• Expertise with Pharmacometric methodologies
(e.g., disease modelling, conc-QT analysis, clinical trial simulation, etc)
• Experts with Modeling and Simulation Software
(NONMEM, GastroPlus and R, Phoenix etc)
• Relevant experience in clinical drug development
of both NCEs and biologicals
• Excellent verbal, written, presentation and organizational skills

Interested individuals are encouraged to apply at the following link:
https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?partnerid=25617&sit=
eid=5091&jobid=1227322
Hiring manager: Joseph Kim, PhD, Senior Director, Quantitative Clinical Dev=
elopment, PAREXEL, Durham


Joseph Kim, PhD, RPh
Senior Director, Quantitative Clinical Development
PAREXEL International
USA
Next 000:
June 7-8: Day off
T +1 919.294.5167
M +1 919.265.9538
Joseph.kim_at_PAREXEL.com<mailto:Joseph.kim_at_PAREXEL.com>

Kind regards,

Laura Iavarone
Scientific Director
Quantitative Clinical Development

PAREXEL International
The Quays, 101-105 Oxford Road
Uxbridge, Middlesex, UB8 1LZ, UK
T +44 (0)1895 614933
M +44 (0)7917218143

laura.iavarone_at_PAREXEL.com<mailto:laura.iavarone_at_PAREXEL.com>
www.PAREXEL.com<http://www.parexel.com/>




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Received on Mon Jun 11 2018 - 03:09:40 EDT

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