Vice President, Clinical & Regulatory Affairs - Mid-Atlantic
Qualifications:
• Advanced degree in science or medicine. MD is preferred.
• Knowledgeable, experienced, and successful in all aspects of the design, conduct, and evaluation of clinical trials of ethical pharmaceuticals.
• Extensive successful and harmonious contact experience with US regulatory agencies. Experience with international regulatory agencies, particularly European.
• Detailed working knowledge of the IND, NDA, PMA and 510k systems, including an awareness of how to get things done and the right questions to ask.
• Demonstrated ability to work closely with other executives in a developing pharmaceutical company environment on a wide range of activities, including strategic issues and new business development.
• 5-10 years industry-based Clinical Drug Development experience in Device and Pharmaceutical or Biotech companies with a track record of success.
• Preference in having worked in both big pharma as well as emerging specialty pharma.
• Drug delivery expertise is a must.
• Therapeutic expertise in injectables, pain, women’s health, CNS.
