- Member of taskforce to harmonize and standardize processes/documents for Clinical Development across branches of large Pharmaceutical company.
- organized and supervised local and international Phase I-iii trials, including orphan indication, mainly in (but not exclusive)
- rheumatoid arthritis
- multiple sclerosis
- lamellar ichthyosis
- allergies (rhinitis, conjunctivitis)
- set-up Clinical operations department in starting biotechs.
- coordinated (GXP) Quality Management System and Document Management system set-up.
Associate Director Clinical OperationsNovember 2012 --- October 2013
Senior Manager Clinical OperationsJune 2008 --- September 2012
preparation of Phase I-ii Clinical trials with a range of new Small molecules; contacts with key opinion leaders (eur, usa) in the various disease areas, discussing "where to go" for next steps. management of Logistics with 3rd party clinical service providers (cros, central labs, ...)
Director Clinical Operations EURApril 2002 --- March 2008
CRMJanuary 1982 --- January 2001
CRA/CRMJanuary 1982 --- January 1997
LinkedIn Assessment :
Certificate in Italian from Centre for Adult Education (evening classes) in 2010
Master in Translation, English & Spanish from HIVT (RUCA) in 1981
Area / Region