Clinical PK/PD Modeler

Job description

Site Name: UK - London - Brentford, UK - Middlesex - Stockley Park
Posted Date: Dec 4 2019

A new position has come up in our Clinical Pharmacology Modelling and Simulation Group (CPMS) at our Stockley Park site. This is an excellent role to use quantitative clinical pharmacology to accelerate the delivery of new medicines to patients by enhancing drug program efficiency and business decision quality. The work directly supports our mission to help our patients do more, feel better and live longer.

The clinical PK/PD modeler will provide technical therapeutic, and product development support for GlaxoSmithKline projects across all therapeutic areas.  Individuals will ensure the optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development, risk management, and product registration. 

Key Responsibilities include, but are not limited to:

Responsibilities generally commence at pre-clinical candidate selection and continue through product lifecycle management. 

Principle accountabilities include both modelling/simulation activities and clinical pharmacology support:

  • Plan, execute and report translational drug-disease modelling, exposure-response analysis, simulation-based trial design and population clinical pharmacology
  • Contribute to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
  • Apply innovative methods such as longitudinal exposure-response analysis, model-based meta-analysis and item-response analysis to improve data use and trial efficiency
  • Present strategy and defend outcome of model-based approaches to internal governance boards and regulatory agencies
  • Promote model-informed drug discovery and development through external collaboration, journal publication and conference presentation

Basic Qualifications/Competencies:

  • A doctorate relevant to Quantitative Clinical Pharmacology, and experience in using modelling/simulation to solve practical problems in industry or academia
  • Proven skills in pharmacokinetic-pharmacodynamic and longitudinal disease modelling; and verifiable proficiency in pharmacometric tools NONMEM, Monolix, R or SAS
  • Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design and endpoints
  • Demonstrated aptitude for productive collaboration in a multi-discipline team, with effective communication and taking personal accountability for timely delivery of results
  • Clear evidence of ability to make sound judgement in complex situations, and adapt to changing business needs by prioritising multiple tasks

Preferred Qualifications:

  • Experience in the design, analysis, interpretation and reporting of Clinical PK and PK/PD studies. 
  • Experience or demonstrated aptitude in the application of clinical PK and PK/PD to the drug development process. 
  • Knowledge of pharmacology, biology, drug metabolism, biopharmaceutics, regulatory affairs, therapeutics and commercialization such that he/she can assist in managing these interfaces and ensure that CPMS input meets their needs.

 

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers.  As a candidate for a role, we want you to feel the same way.

We’re open to all talent – whatever your gender, disability, marital status, religion or belief, age, race, sexual orientation, ethnic or national origin.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.  You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it.  Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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