Director Clinical Pharmacology, Oncology
We are seeking a Director-level Quantitative Clinical Pharmacologist for our Clinical Pharmacology Modelling and Simulation (CPMS) Oncology team. CPMS is a science driven group delivering clinical pharmacology and modelling & simulation excellence to development programs. In this role you will have the opportunity to work on both small molecules and biologics in the Oncology area. There may be opportunities in the future to contribute to programs in other therapy areas as well.
• 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 model-informed drug discovery & development (MID3) strategies and approaches by publishing in peer-reviewed journals and presenting at scientific conferences
• Advanced degree such as PhD, PharmD and MD
• Experience in Clinical Pharmacology, Pharmacometrics, Model-Informed Drug Discovery and Development Strategies
• Knowledge of or ability to quickly learn the mechanisms, endpoints, disease understanding and treatment approaches in Oncology and other relevant therapy areas
• Understanding of Pharmacokinetic, 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, analysing and reporting clinical studies, with a simulation- or modeling-based approach where appropriate.
• Familiarity with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLA
• Ability to apply appropriate FDA, EMA and ICH guidelines in the design of clinical development plans and studies for GSK.
• Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results
• Ability to effectively multi-task and deliver results on time
• Demonstrated expertise in drug development of novel oncology therapeutics
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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