Dr. Karsten Roth
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Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Karsten Roth
- Current 11 years and 6 months, since Dec 2014
Director Clinical Operations and Pharmacovigilance / Clinical Development Lead
Cinfa Biotech GmbH
• Member of the Cinfa Biotech Management Board • Clinical Development Lead • Head of Pharmacovigilance • Supervision of global clinical teams • Operational oversight of preclinical, clinical and post approval activities • Management of a Marketing Authorisation Application (MAA) • Presentation and discussion at regulatory agencies, incl. EMA, national European Health Authorities, FDA and PMDA • Budget oversight for clinical, preclinical and Pharmacovigilance activities
- 1 year and 10 months, Feb 2013 - Nov 2014
Head Clinical Development Immunology
Sandoz Gruppe / HEXAL AG (a Novartis company) Biopharmaceutical
Oversight of a team located in Europe and US Oversight of design, conduct and reporting of 4 global clinical development programs for biopharmaceuticals (EU, USA, Japan) in auto-immune indications (RA, Psoriasis, Crohn’s disease), MS and endocrinology covering clinical trials from phase 1- 3 and phase 4
- 3 years and 11 months, Mar 2009 - Jan 2013
Head Clinical Development Hematology
Sandoz Biopharmaceuticals, Novartis Pharma AG
Global Lead for Clinical Development programs at Sandoz Biopharmaceuticals/Novartis Pharma
- 1 year and 11 months, Apr 2007 - Feb 2009
Global Clinical Program Leader
Sandoz Biopharmaceuticals, BU of Novartis Pharma AG
Global Lead of clinical biopharmaceutical development program
- 6 years and 2 months, Feb 2001 - Mar 2007
Senior Manager Clinical Research
Astellas Pharma Europe
- 3 years and 1 month, Feb 1998 - Feb 2001
Senior Clinical Research Scientist
Novartis Pharma Basel
- 2 years and 8 months, Jun 1995 - Jan 1998
Project Manager CRO
Quintiles
Ausbildung von Karsten Roth
- 2001 - 2003
Pharmaceutical Medicine
Universtät Basel, Switzerland
- 2000 - 2005
Project Management
George Washington University, Washington DC, USA
- 1985 - 1993
Biochemie
Justus - Liebig Universität Giessen, Germany
Sprachen
German
English
Spanish
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