SantoshThomasVargheseMD

Summary

• Over 19 years of U.S. and global pharmaceutical industry experience in direct and matrix organizations. Lead project teams and medical groups in clinical development and medical affairs. Therapeutic experience in Cardiovascular/Thrombosis, Endocrinology/Metabolism, Allergy, Respiratory, Immunotherapy, Multiple Sclerosis, CNS Disorders, Anti-Infectives, Men's Health, Women's Health/Gynecology, Reproductive Endocrinology, Osteoarthritis, Rheumatoid Arthritis, and Device Technology. A proven track record of increasing responsibility and scientific credibility demonstrated by abstracts and journal publications in multiple therapeutic areas. Strong leadership skills, strategic thinking, vision, and integrity. Key accomplishments include:
  - Lead successful new indication and new formulation negotiations with FDA resulting in a two year savings on the filing timeline.
  - Lead successful interactions and negotiations with OPDP (DDMAC) on promotional campaigns.
  - Lead successful "out of the box" style Phase IV programs.
  - Experience in Risk Management Programs: REMS (US), RMP (EU).
  - Experience in Corporate Integrity Agreements.
  - Experience in departmental/corporate re-organizations and optimization.
  - Experience in developing Medical Affairs, Pharmacovigilance, Regulatory Affairs, Compliance, and QA organizations.
  - Strong Key Opinion Leader relationships throughout the world in multiple therapeutic areas.