[NMusers] Quantitative Clinical Pharmacology Positions at GlaxoSmithKline

From: Chao Chen <chao.c.chen_at_gsk.com>
Date: Thu, 23 Apr 2015 17:02:51 +0000

The department of Clinical Pharmacology Modelling and Simulation at GlaxoSm=
ithKline is recruiting several quantitative clinical pharmacologists, at le=
vels from Scientist to Senior Director. Successful candidates will have the=
 opportunity to work on both small molecules and biologics in therapy areas=
 including immunoinflammation, metabolic pathways, respiration, oncology, i=
nfection, neurosciences, dermatology, cardiovascular diseases and others. P=
ositions are based in Stevenage and Uxbridge in the UK and in Upper Merion =
in the USA.
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
GlaxoSmithKline provides a supportive environment for scientists who are as=
pired to learn, to contribute and to make impact on business decisions thro=
ugh innovation. We have several vacancies. The position level for a success=
ful candidate will be based on the person's skills and experience. To apply=
, please visit our website (http://www.gsk.com/en-gb/careers/search-jobs-an=
d-apply/) quoting req ID WD20837.

Chao Chen, PhD
Interim Global Head,
Clinical Pharmacology Modelling & Simulation
GlaxoSmithKline R&D
chao.c.chen_at_gsk.com<mailto:chao.c.chen_at_gsk.com>



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Received on Thu Apr 23 2015 - 13:02:51 EDT

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