Karsten Roth
Director
Clinical Operations
Cinfa Biotech
Spain
Biography
Karsten leads the clinical development activities at Cinfa Biotech. He is responsible for the development and implementation of preclinical, clinical and post-approval clinical activities. In this role, he supervises the clinical operations team and manages the clinical stakeholders network. Karsten has over 20 years of experience in the pharmaceutical industry, having held various international executive positions with a strong focus on clinical development across several therapeutic areas. He gained substantial experience in setting up quality management systems, including SOP implementation. In his former positions, he contributed to marketing authorisation submissions for the US and EU, presentations at FDA, PMDA and EMA meetings, and was involved in setting up and leading global advisory boards. Karsten holds a PhD in biochemistry, a postgraduate degree in pharmaceutical medicine and a Master in project management from the George Washington University. Karsten leads the clinical development activities at Cinfa Biotech. He is responsible for the development and implementation of preclinical, clinical and post-approval clinical activities. In this role, he supervises the clinical operations team and manages the clinical stakeholders network. Karsten has over 20 years of experience in the pharmaceutical industry, having held various international executive positions with a strong focus on clinical development across several therapeutic areas. He gained substantial experience in setting up quality management systems, including SOP implementation. In his former positions, he contributed to marketing authorisation submissions for the US and EU, presentations at FDA, PMDA and EMA meetings, and was involved in setting up and leading global advisory boards. Karsten holds a PhD in biochemistry, a postgraduate degree in pharmaceutical medicine and a Master in project management from the George Washington University.
Research Interest
development and implementation of preclinical, clinical and post-approval clinical activities.
