Over 25 years experience in Clinical Operations, from Medical Writing through CRA/CRM to Director Clinical Operations (pharma/biotech).
- 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 Operations
November 2012 --- October 2013
Senior Manager Clinical Operations
June 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 EUR
April 2002 --- March 2008
January 1982 --- January 2001
January 1982 --- January 1997
Certificate in Italian from Centre for Adult Education (evening classes) in 2010
Master in Translation, English & Spanish from HIVT (RUCA) in 1981