Job Summary

A staffing company is in need of a Telecommuting Clinical Pharmacology Director.

Individual must be able to fulfill the following responsibilities:

• Providing clinical pharmacology expertise on protocol design, clinical study reports, investigator brochures, DSUR's, and provide scientific expertise in the preparation of clinical pharmacology sections
• Directing and/or managing clinical pharmacology functions
• Providing expertise in clinical pharmacology related matters with regulatory authorities

Skills and Requirements Include:

• Response to questions from regulators, teleconferences, Face-to-face Meetings, Oral Explanations, etc
• PhD in Pharmacology or Pharmaceutical Sciences or related Sciences or equivalent combination of education with applicable job experience
• A minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry
• Extensive experience with regulatory requirements, preparation of the clinical pharmacology sections of NDAs, BLAs, understanding of FDA regulations, GCP and/ SOPs in clinical research