Dear all,
We wish to announce a senior-level position (Sr. Scientist to Director) in the
Clinical Pharmacology Modelling and Simulation (CPMS) group of GlaxoSmithKline
(GSK) in China. This position is based in either Shanghai or Beijing.
GSK provides a supportive environment for scientists who are aspired to learn,
to contribute and to make impact on business decisions through innovation. The
position level for a successful candidate will be based on the person's skills
and experience. As a member of our global CPMS department, you have the
opportunities to work as the clinical pharmacology lead for global and China
development/registration projects.
Below are the responsibilities and qualifications for the position. If
interested, please send your CV to:
[email protected]<mailto:[email protected]>.
Sincerely,
Peiming Ma
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 predicting human dose range, characterising
dose-response relationship and justifying dose recommendations for special
populations
* Develop mathematical and statistical models to understand a disease,
its progression, and pharmacodynamics and pharmacokinetics; conduct
meta-analyses as appropriate to maximise data use; conduct simulations to
assess trial design performance
* 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, biologists, physicians and drug
metabolism scientists
* 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
* Knowledge of or ability to quickly learn the mechanism, endpoints,
progression and treatments of relevant diseases
* 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, analysing 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
* 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