Dear all,
GlaxoSmithKline (GSK) is hiring Clinical Pharmacologists (Sr. Scientist to
Associate Director) in the Clinical Pharmacology Modelling and Simulation
(CPMPS) group in China. As a member of our global CPMS department, you will
have the opportunities to work as the clinical pharmacology lead for China or
Asia development/registration projects.
Below are the responsibilities and qualifications for the position. If you are
interested in this position, please send your CV to
[email protected]<mailto:[email protected]>.
Thank you,
Xuan
Xuan Zhou Ph.D.
Director of Clinical Pharmacology, Modelling & Simulation
China R&D, GSK
Responsibilities May Include
* Contribute, as a member of a multi-discipline team, to the design of an
efficient clinical development program and a robust registration package
* Play a central role in justifying dose recommendations for Chinese
population by using quantitative approaches
* Design and interpret clinical pharmacology studies, including those to
evaluate potential effects of intrinsic and extrinsic factors on
pharmacokinetics and pharmacodynamics
* Write sections of drug development and registration documents such as
clinical trial protocols and reports, clinical investigator brochures and
regulatory submission packages
* Present and defend quantitative clinical pharmacology plans and results
through interaction and negotiation with internal governance committees and
external regulators
* Innovate through working effectively with colleagues in the department
and others such as statisticians, physicians and regulatory affair staffs
* Learn and apply emerging modelling and simulation methodologies with a
view to enhance clinical program efficiency and investment decision quality;
collaborate with external field-leading teams for methodology application
* Promote model-informed drug development approach by publishing in
peer-reviewed journals and presenting at scientific conferences
Basic And Preferred Qualifications Are
* Advanced training with a degree such as PhD, PharmD and MD to enable a
successful career in quantitative clinical pharmacology in pharmaceutical
research and development
* Understanding of pharmacokinetic and pharmacodynamic principles and
commonly applied models; working knowledge of common tools for quantitative
clinical pharmacology such as NONMEM, R, WINNONLIN, Simcyp, SAS and MATLAB
* Experience in designing, analyzing and reporting clinical studies, with a
simulation- or modelling-based approach where appropriate
* Familiarity with regulatory submission documents such as CTAs, INDs,
NDAs, MAAs and BLAs
* Knowledge of, or ability to quickly learn, the mechanism, endpoints,
progression and treatments of relevant diseases
* Ability to communicate clearly and succinctly with the audience in mind,
both orally and in writing
* Ability to build effective collaboration while taking personal
accountability for delivery of quantitative clinical pharmacology results
* Sound judgement, analytical mindset and problem-solving skills
* Ability to effectively multi-task and deliver results on time