Senior Consultant Clinical Development / Regulatory Affairs

Tonke van Bragt joined Kinesis Pharma B.V. in May 2009 as a senior Consultant Clinical Development and Regulatory Affairs for drug development programs, especially regarding clinical development and regulatory affairs. She is a member of multidisciplinary drug development teams within Kinesis Pharma. In addition, she is responsible for the design, execution and interpretation of clinical studies, especially Phase I/IIa studies. Furthermore, she is experienced in the preparation and review of clinical trial related and regulatory documents.

From August 2008 she held the position of consultant drug development and program manager at the contract research organization NOTOX B.V. in the Netherlands. She acted as an external and internal consultant and project manager in designing and managing preclinical developmental projects.

She joined N.V.Organon in the Netherlands (now Merck Sharp & Dohme BV) in 1993 and had several positions. From 2002 to 2008 she worked for the Department of Clinical Pharmacology and Kinetics in the position of Clinical Pharmacology Research Manager. In this position she designed and managed clinical pharmacology studies (a.o. First-in-Man studies). For these studies she had contact with several Contract Research Organizations. From 1993 to 2002 she worked for the Regulatory Affairs Department as Regulatory Affairs Scientist. Her responsibilities were to manage all regulatory activities for global submissions for compounds in development.

In both positions she was a member of several drug development teams and provided input to various drug development plans.

From 1990 to 1993 she worked for the Dutch Poisons Information Centre (NVIC) of the National Institute for Public Health and the Environment (RIVM), Utrecht, the Netherlands, as a literature scientist.

Drs. Van Bragt graduated in Medical Biology (main subject Teratology) at the University of Utrecht, The Netherlands, in 1990.