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FW: Job opportunity: Associate Director, Clinical Pharmacology, Modelling & Simulation, Parexel - Job ID 60838BR - Any Region - Home Based

From: Iavarone, Laura <Laura.Iavarone>
Date: Wed, 26 Aug 2020 07:32:23 +0000

Parexel has a new home based opportunity for an Associate Director, Clinica=
l Pharmacology, Modelling & Simulation. The Associate Director ensures the =
strategic application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD=
), and Modeling & Simulation (MS) principles towards efficient drug develop=
ment. Individuals will provide support for PK/PD strategy and interpretatio=
n to other parexel internal Strategic Business Unit and clients. The Associ=
ate Director will provide quality services to clients.

Key Accountabilities:
* To analyze clinical PK/PD data as a member of several multidiscip=
linary development program teams.
* To work with clinical teams to design PK/PD components in various=
 study designs such as first-in-human, bioequivalence and drug-drug interac=
tion studies.
* Responsible for authoring or contributing to clinical PK/PD secti=
ons of relevant documents.
* Serve as a primary source of scientific support for the design, a=
nalysis, reporting, and presentation of PK/PD modeling and simulation initi=
atives, including population PK/PD analyses for all phases of development.
* Review of scientific documentation including Clinical Study Proto=
cols, SOPs, Statistical Analysis Plans and Clinical Study Reports.
* Provides Quality Control (QC) for WinNonlin and NONMEM analysis.
* Review of derived PK/PD data generated by PK Analyst.
* Maintaining a strong working knowledge of pharmacology, biology, =
therapeutics, drug metabolism, bioanalysis, and biopharmaceutics.
* Developing and maintaining a relationship with internal and exter=
nal clients and scientists.
* Provides leadership and development of the team to ensure their p=
erformance meets and or exceeds both the business and their own personal go=
* Maintain a positive, results orientated work environment, buildin=
g partnerships and modeling teamwork, communicating to the team in an open,=
 balanced and objective manner.
* To provide scientific support and advice to relevant Parexel staf=
* Provide training and guidance and act as a mentor to less experie=
nced departmental members.
* Reviewing/Authoring scientific publications, abstracts, posters.
* Excellent knowledge of PK and PD principles.
* Strong experience with the design and implementation of Model-Bas=
ed Drug Development strategies.
* Knowledge of Pharmacometric methodologies (e.g., conc-QT analysis=
, clinical trial simulation)
* Experience in basic PK analysis tool such as WinNonlin/Phoenix
* Experience in other software such as NONMEM, GastroPlus and R is =
* Experience in clinical drug development of both NCEs and biologic=
* Excellent interpersonal, verbal and written communication skills.
* Strong clinical/scientific writing skills.
* Client focused approach to work ethic.
* Exhibits and promotes a flexible attitude with respect to work as=
signments and new learning.
* Ability to manage multiple and varied tasks with enthusiasm and p=
rioritize workload with attention to detail.
* Willingness to work in a matrix environment and to value and prom=
ote the importance of teamwork.
* Demonstrated understanding of the drug development process and a =
knowledge of FDA and EMEA guidelines.

Knowledge and Experience:
* Typically 6-10 years' experience in drug development.

* Advanced science degree (PhD, PharmD) and/or relevant experience.

Please apply via the link below.

Thank you

Laura Iavarone
Scientific Director
Clinical Pharmacology, Modeling & Simulation
Parexel International
The Quays, 101-105 Oxford Road
Uxbridge, Middlesex, UB8 1LZ, UK
T +44 (0)1895 614933
M +44 (0)7917218143


Received on Wed Aug 26 2020 - 03:32:23 EDT

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