Manager, Clinical Pharmacology
The department of Clinical Pharmacology Modelling and Simulation (CPMS) at GlaxoSmithKline is recruiting a Quantitative Clinical Pharmacologist. CPMS is a science driven group delivering clinical pharmacology and modelling & simulation excellence to development programs. A successful candidate will have the opportunity to work on both small molecules and biologics in the HIV / Infectious Disease area although there may be opportunities in the future to contribute to programs in other therapy areas.
• Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development programs and robust registration packages
• Play a central role in predicting human dose range, characterising dose-response relationship and justifying dose recommendations for special populations
• Develop mathematical models to understand a disease, its progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance
• Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics
• Identify opportunities to utilize in silico PBPK approaches to replace in vivo clinical studies to explore the impact of DDI and special populations on PK where appropriate
• 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 other matrix team members, including: 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 clinical pharmacology strategies and approaches by publishing in peer-reviewed journals and presenting at scientific conferences
• 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 diseases in oncology and other relevant therapy areas
• 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
• Familiarity with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs
• Experience in designing, analysing and reporting clinical studies, with a simulation- or modelling-based approach where appropriate
• Understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical development plans and studies
• 2 years post-graduation experience in a fellowship or industry environment
• 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
• Preferred requirement is demonstrated experience in drug development of novel oncology therapeutics
GlaxoSmithKline provides a supportive environment for scientists who are aspired to learn, to contribute and to make impact on business decisions through innovation, expertise, and influence.
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