Summary

The Medical Director-Clinical Research, North America reports to the Executive Medical Director.  The incumbent is responsible for developing and implementing product development strategies initially in the Gastroenterology therapeutic area but later may involve in other therapeutic areas as derived from the company's pipeline and/or in licensed development products.  While the individual is expected to manage the conduct of clinical trials in the US, there is a strong component involving participation in global project development teams.  The Medical Director will be expected to undertake all the duties normally associated with the execution of clinical trials and to establish clinical advisory boards in the areas of product development.

Essential Duties and Responsibilities

• Monitor safety and efficacy of any compound in development by the company
• Participate in the  safety monitoring and monitoring systems for clinical studies being managed by Clinical Research
• Participate in cross functional process oriented activities as required
• Develop medical efficacy and safety endpoints
• Write protocol synopsis and full protocols as required
• Contribute in the regulatory process during the development and at regulatory submission
• Interact with global marketing
• Participate in publication planning
• Participate in scientific meetings
• Participate in advisory boards as required
• Liaise with external scientists to  plan and evaluate ongoing product development
• Evaluate in-license projects as requested
• Provide clinical guidance and training to in-house staff
• Participate at Investigator meetings as required
• Work closely with International Project Development Teams to ensure effective global development projects
• Seek to continuously improve management skills

Qualification Requirements

• MD degree or equivalent - at least three years industry pharmaceutical development experience or equivalent
• Accreditation in a medical subspecialty (ie: GI, Internal Medicine)