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[NMusers] Job position in Clinical Pharmacology Modelling & Simulation at GlaxoSmithKline in China

From: Peiming Ma <peiming.p.ma_at_gsk.com>
Date: Fri, 26 Feb 2016 05:58:06 +0000

Dear all,
We wish to announce a senior-level position (Sr. Scientist to Director) in =
the Clinical Pharmacology Modelling and Simulation (CPMS) group of GlaxoSmi=
thKline (GSK) in China. This position is based in either Shanghai or Beijin=
g.
GSK provides a supportive environment for scientists who are aspired to lea=
rn, to contribute and to make impact on business decisions through innovati=
on. The position level for a successful candidate will be based on the pers=
on'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 inte=
rested, please send your CV to: peiming.p.ma_at_gsk.com<mailto:peiming.p.ma_at_gs=
k.com>.
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 pac=
kage

* Play a central role in predicting human dose range, characterisin=
g dose-response relationship and justifying dose recommendations for specia=
l populations

* Develop mathematical and statistical models to understand a disea=
se, its progression, and pharmacodynamics and pharmacokinetics; conduct met=
a-analyses as appropriate to maximise data use; conduct simulations to asse=
ss trial design performance

* Design and interpret clinical pharmacology studies, including tho=
se to evaluate potential effects of intrinsic and extrinsic factors on phar=
macokinetics and pharmacodynamics

* Write sections of drug development and registration documents suc=
h as clinical trial protocols and reports, clinical investigator brochures =
and regulatory submission packages

* Present and defend quantitative clinical pharmacology plans and r=
esults through interaction and negotiation with internal governance committ=
ees and external regulators

* Innovate through working effectively with colleagues in the depar=
tment and others such as statisticians, biologists, physicians and drug met=
abolism scientists

* Learn and apply emerging modelling and simulation methodologies w=
ith a view to enhance clinical program efficiency and investment decision q=
uality; collaborate with external field-leading teams for methodology appli=
cation

* 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 ena=
ble a successful career in quantitative clinical pharmacology in pharmaceut=
ical 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 a=
nd commonly applied models; working knowledge of common tools for quantitat=
ive clinical pharmacology such as NONMEM, R, WINNONLIN, Simcyp, SAS and MAT=
LAB

* 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, IN=
Ds, NDAs, MAAs and BLAs

* Ability to communicate clearly and succinctly with the audience i=
n mind, both orally and in writing

* Ability to build effective collaboration while taking personal ac=
countability 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




Received on Fri Feb 26 2016 - 00:58:06 EST

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