About
Specialties: Toxicology, Endocrinology, Molecular Biology, Pharmacology, Research, Development, Cooperation with CROs
Experience
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Manager Scientific Development at Klosterfrau Healthcare Group
Oct 2021 - Present · 5 yrs 1 mo
Tackling Current and Future Health Challenges by Creative Ideation and Scientific Development of Medicinal Products, Food Supplements and Foods for Special Medical Purposes.
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Bionorica SE (11 yrs 8 mos)
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Clinical & Scientific Advisor R&D
Mar 2018 - Sep 2021 · 3 yrs 7 mos
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Nürnberg und Umgebung, Deutschland
Scientific support of two key products
- Development of research strategy (non-clinical and clinical) in close cooperation with management, marketing division, regulatory affairs and other stakeholders
- Planning, initiation and supervision of outsourced non-clinical (toxicological and pharmacological) research projects
- Support and scientific evaluation of non-clinical and clinical IIT projects
- Support of NIS projects
- Close cooperation with international key opinion leaders in area of indication to develop IIT strategy
- Regulatory support of products including work on regulatory documents (CTD, NCO, SmPC, PSUR) and letters of deficiency (writing of scientific statements)
- Publication of peer reviewed research papers and poster presentations
- Acting as external and internal expert giving scientific presentations on products to HCPs and medical marketing colleagues
Main internal contact person for all toxicological issues
Creative support of new drug development strategies development
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Manager Preclinical R&D
Jan 2013 - Mar 2018 · 5 yrs 3 mos
In my current position I am responsible for the planning and conduct of GLP and non-GLP pharmacological and toxicological studies in cooperation with CROs and academic institutions to promote marketing authorization of pharmacological products as well as company marketing strategies.
Currently, I am intensely in charge of one specific product at different stages of marketing authorization.
Furthermore, I am involved in keeping product documentation up to date (CTD, SPC, PSUR, etc.).
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Junior Manager Pharmacology/Toxicology
Feb 2010 - Dec 2012 · 2 yrs 11 mos
In this position I am responsible for the planning and conduct of GLP and non-GLP pharmacological and toxicological studies in cooperation with CROs to promote marketing authorization of pharmacological products as well as company marketing strategies.
Currently, I am intensely in charge of one specific product at different stages of marketing authorization.
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Post Doc at Abbott Laboratories
Apr 2008 - Feb 2010 · 1 yr 11 mos
Occupation as Study Director (GLP and non-GLP)
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Intern at Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Dec 2007 - Feb 2008 · 3 mos
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Research Associate at Deutsche Sporthochschule Köln (DSHS)
Apr 2003 - May 2007 · 4 yrs 2 mos