Professional summary

- Broad experience in drug and biologics clinical development clinical development in a variety of therapeutic areas
- Development of clinical and regulatory strategy
- Management of clinical studies in all phases of development
- Strategic Project Management and Portfolio Review
- Authoring and compiling protocols and NDAs
- Communications with regulatory agencies (FDA, EMEA, Ministry of Health- Japan, Health Canada, etc)
- Management of large clinical R&D teams

Engagement overview

An online or via phone definition of the project  - an estimate of the time/effort to complete the project/assignment


• International biotechnology and plasma fractionation company located in the New York - New Jersey area with

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