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About AstraZeneca
Karen Gotting-Smith, PhD
Vice President—Clinical Development
Karen Gotting-Smith
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Responsibilities

Karen Gotting-Smith became a leader in AstraZeneca Clinical Development in September 2005. Karen is responsible for the US Clinical Development region, which is one of three regions within AstraZeneca that are responsible for the design and delivery of clinical development programs. These programs span the AstraZeneca portfolio from phase I to phase IV clinical trials, for products already available and for new products in development.

Prior experience

Karen has 19 years experience in global drug development both in clinical development and global leadership of cross-functional product teams and has worked on registration programs in the US, Europe and Asia as well as life cycle management programs in both the oncology and cardiovascular therapy areas.

Prior to her current role, Karen served as Global Product Director for CRESTOR® (rosuvastatin calcium). She led the cross-functional global product team through regulatory work in many countries, securing investment proposals for life cycle plans and led the management and communication of the overall benefit:risk profile of the product – including the set up of rosuvastatininformation.com and the design and delivery of a global pharmacoepidemiology program.

Education

  • Bachelor of science in genetics and zoology, University College in Cardiff, Wales
  • PhD in breast cancer research, Tenovus Institute for Cancer Research at the Welsh National School of Medicine
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