Director, Lead Global Product Safety Physician (Unapproved products, Oncology) Posted October 1, 2008 Summitt, NJ

JOB DESCRIPTION: Purpose •To create and maintain a single interpretation of global safety data for defined products in development •To identify and manage safety concerns with development products •To assist the clinical development study teams in pursuit of team goals •To provide a robust assessment of developmental product safety upon which marketed product safety surveillance may be based Context and Responsibilities The Director, Lead Global Product Safety Physician (unapproved products, Oncology), is: A global role, based in Summit, NJ Reports (at a minimum) to:  Head of Global Trials Safety Surveillance  Responsible for: •Identifying and managing safety concerns for pre-approval  products •Assisting clinical development trials teams in the identification and handling of product safety concerns •Creating co-ordination at the product level across the Global Drug Safety Dept •Maintaining knowledge of safety profiles for treatments in a specific therapeutic area, including both  and competitor products • Preferred Role Qualifications, Experience, Knowledge & Competencies The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education and experience or the equivalent. Qualifications •Minimum of MD (or international equivalent) plus accredited residency •Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred Experience •Ten (10) years relevant clinical experience, including training ctives JOB REQUIREMENTS: •Minimum of Five (5) years pharmaceutical/biotechnology industry experience Knowledge •Mastery of global regulatory requirements for pharmacovigilance, have significant experienced in Risk Management •Clinical knowledge of the oncology therapeutic area patient populations and drug class •Knowledge of clinical research techniques and analysis methods •Issue and crisis management