A new position has come up in our Clinical Pharmacology Modelling and Simulation Group (CPMS) at our Greater London site. This is an excellent role to use quantitative clinical pharmacology to accelerate the delivery of new medicines to patients, by enhancing drug development 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 Modelling & Simulation (MS) principles towards efficient drug development, risk management, and product registration. 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 PK/PD 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. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: * Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. * Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. * Continuously looking for opportunities to learn, build skills and share learning. * Sustaining energy and well-being * Building strong relationships and collaboration, honest and open conversations. * Budgeting and cost-consciousness At GSK, we develop therapies of various modalities for a broad range of indications. As a member of a global department with diverse expertise, you will enjoy a highly supportive environment for scientific innovation, business impact and professional growth. This position is open for application till Wednesday 5th August 2019. Interested persons are encouraged to apply online here<https://jobs.gsk.com/en-gb/jobs/230574?lang=en-us&previousLocale=en-GB>. Chao Chen Clinical Pharmacology Modelling & Simulation GlaxoSmithKline R&D GSK monitors email communications sent to and from GSK in order to protect GSK, our employees, customers, suppliers and business partners, from cyber threats and loss of GSK Information. GSK monitoring is conducted with appropriate confidentiality controls and in accordance with local laws and after appropriate consultation. ________________________________ This e-mail was sent by GlaxoSmithKline Services Unlimited (registered in England and Wales No. 1047315), which is a member of the GlaxoSmithKline group of companies. The registered address of GlaxoSmithKline Services Unlimited is 980 Great West Road, Brentford, Middlesex TW8 9GS.
