Ifat Klein

Background

About Ifat Klein

Rich academic background, including a Ph.D in Medical science. M.Sc in physiology and pharmacology, B.Sc in nutrition science. Graduated a CRA course, Regulatory course and business school. • Interested to integrate into Pharmaceutical or medical devices companies in senior positions in the clinical field. • Vast experience in clinical trial development and management in pharma and medical devices which include: phases I-IV studies, protocols development and writing, CRF design, preparation of regulatory documents, working with global and local vendors (CROs, DM, Labs, Statisticians, etc). • Director of clinical trials in the US, Europe and Israel. • Managing people and projects for more than 20 years. • Experience in pre-IND and IND development preparation and submissions • Experience in NDA preparation and submissions • Responsible for safety data collection and preparation the annual safety report with MedDra classification (DSUR). • Work in collaboration with external advisors with submissions of regulatory documents for the CAs, EMEA, Health Canada, FDA and other regulatory authorities. • Experience in clinical support for marketing and customers training globally. This includes experience in preparation of clinical presentations, marketing material for the distributors and exhibitions. • Professional skills in synchronizing, multitasking, and managing large projects which include: teamwork organization, teaching/tutoring, standing in deadlines and strong ability to prioritize activities. • Certified Clinical Research Associate (CRA).