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Job position in Clinical Pharmacology Modelling & Simulation at GlaxoSmithKline in Shanghai

From: Peiming Ma <>
Date: Sun, 6 May 2018 23:08:14 +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 GlaxoSmithKline (GSK) in Shanghai.

GSK provides a supportive environment for scientists who aspire 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 China and global development/registration projects.

Below are the responsibilities and qualifications for the position. If interested, please send your CV to:<><>.

Peiming Ma
GSK Shanghai R&D

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, characterizing dose-response relationship and justifying dose recommendations for special population
  * Develop mathematical and statistical models to understand a disease, its progression, and pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to maximize 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, 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
  * 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

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Received on Sun May 06 2018 - 19:08:14 EDT

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