Please can you post the below? Thanks!
Laura
Parexel has a new home based opportunity for an Associate Director, Clinical
Pharmacology, Modelling & Simulation. The Associate Director ensures the
strategic application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD),
and Modeling & Simulation (MS) principles towards efficient drug development.
Individuals will provide support for PK/PD strategy and interpretation to other
parexel internal Strategic Business Unit and clients. The Associate Director
will provide quality services to clients.
Key Accountabilities:
* To analyze clinical PK/PD data as a member of several
multidisciplinary 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 interaction
studies.
* Responsible for authoring or contributing to clinical PK/PD sections
of relevant documents.
* Serve as a primary source of scientific support for the design,
analysis, reporting, and presentation of PK/PD modeling and simulation
initiatives, including population PK/PD analyses for all phases of development.
* Review of scientific documentation including Clinical Study
Protocols, 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 external
clients and scientists.
* Provides leadership and development of the team to ensure their
performance meets and or exceeds both the business and their own personal
goals/objectives.
* Maintain a positive, results orientated work environment, building
partnerships and modeling teamwork, communicating to the team in an open,
balanced and objective manner.
* To provide scientific support and advice to relevant Parexel staff.
* Provide training and guidance and act as a mentor to less experienced
departmental members.
* Reviewing/Authoring scientific publications, abstracts, posters.
Skills:
* Excellent knowledge of PK and PD principles.
* Strong experience with the design and implementation of Model-Based
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
desirable.
* Experience in clinical drug development of both NCEs and biologicals.
* 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
assignments and new learning.
* Ability to manage multiple and varied tasks with enthusiasm and
prioritize workload with attention to detail.
* Willingness to work in a matrix environment and to value and promote
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.
Education:
* Advanced science degree (PhD, PharmD) and/or relevant experience.
Please apply via the link below.
https://jobs.parexel.com/job/united-kingdom/associate-director-clinical-pharmacology-modelling-and-simulation/877/16940182
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
[email protected]<mailto:[email protected]>