Cristália, Brazil
Clinical Research Manager
• Over 20 years of experience in drug development (within Academy and Pharmaceutical Companies). Including planning, implementation and management of clinical projects (Phase I / II / III / IV and bioequivalence) required for the registration of new, similar, generic and biosimilar drugs
• Lead of Clinical Biosimilar Program in Brazilian Pharmaceutical Companies in the last 8 years.
• Participation in new molecules entities evaluation and R&D strategic company planning, working together with internal and external multidisciplinary cross-functional teams, including, Formulation, Marketing, Business Development, PMO, Regulatory Affairs , KOLs, Government Affairs, etc
• Clinical Development representative for ANVISA, CONEP, Private-Public-Partnership Meetings, International and National Regulatory Audit and Due Diligence
• Development, tracking and pro-actively management of organization performance metrics ensuring on-time, on-budget delivery; analyzing trends for cross-functional team performance and quality improvements.