text: May lead / support interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards.
  Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies that are efficient in time and money, and hedge risk as needed.
  Provide hands-on participation in the clinical program and trial development process; conceive and execute clinical strategy and contribute clinical expertise for research and development projects in highly competitive therapeutic areas
  Assist in preparation of clinical sections of all relevant documents and regulatory filings (Investigator’s Brochures, INDs, and study reports)
  Assure implementation of latest scientific and clinical thinking as well as guidelines into the clinical development plans, including through interaction with key opinion leaders