Director, Head of Biotechnology
Biosimilar and NTE products, NCS Dept.
TEVA Pharmaceutical Industries
United States of America
Ability to establish the needed NCS package of different molecules (small and biological) in relation to the drug mode of action, clinical stage to be supported and the regulatory requirements. • Experienced in selecting the appropriate CRO based on history, audit and cost. • Experienced in contracting, supervising and monitoring preclinical studies at CROs. • Ability to produce high level NCS protocols and reports according to GLP requirements. • Team player, working in a multidisciplinary matrix environment communicating with different interfaces (like ADME-PK, CMC, QA, Biological Method Development, Finance, Clinic etc.) to produce the best study outcome. • Experienced in communication and consultation with key opinion leaders about the project, results and interpretations. • Experience in writing the NCS texts for regulatory submissions (IB, IND, SA etc.). • Managerial skills:supervision of NCS project leaders in order to follow timelines, work prioritization and to produce the high quality work.
Biological Method Development