Profile

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
- Due diligence for product purchase or inlicensing

Specialties
Clinical Development Strategy
Communications with Regulatory Agencies
Clinical Research Operations
Writing Protocols, CSRs and CTDs

Engagement overview

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

Clients

• International biotechnology and plasma fractionation company located in the New York - New Jersey area with over $600 M in sales
• Large Far East biotechnology company expanding in the US and RoW
• Large Far East Chemical and Pharmaceutical company introducing products in the U

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