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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) from
Translational Sciences for First Time in Human (FTIH) through all Phases 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 sophisticated
PK/PD modeling and simulation initiatives, including population PK/PD analyses
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 making
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
simulation to clients
· Attend regulatory agency interactions as a project clinical
pharmacometric representative
• Assist clinical teams study design PK/PD components in all phases of
clinical drug development such as first-in-human, POC, pediatric PK,
bioequivalence, biosimilar and drug-drug interaction studies
• Review of scientific documentation including Clinical
Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports
• 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&siteid=5091&jobid=1227322
Hiring manager: Joseph Kim, PhD, Senior Director, Quantitative Clinical
Development, 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
[email protected]<mailto:[email protected]>
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
[email protected]<mailto:[email protected]>
http://www.parexel.com/
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