The company develops first-in-class and best-in-category therapeutics and is advancing its late-stage drug candidates for central nervous system disorders (with an NDA filed March 2010), and cardiovascular diseases , Phase 3 initiated November 2009), to be followed by promising drug candidates in other major indications including asthma, diabetes, and pain. The company combines its drug development and biomarker expertise to develop products with enhanced efficacy and tolerability. The VP, Medical Affairs, will provide overall medical direction for the development work within a cross-functional team to provide clinical expertise and leadership for these drug development programs. Major responsibilities will include implementation of clinical development strategies; protocol design; medical supervision of clinical trials or of CROs; medical/clinical input to commercialization efforts; regulatory communications and interactions; and direct oversight of medical affairs personnel. The successful candidate will be responsible for key interactions with both internal and external customers including current and potential investors. This position reports to the EVP&Chief Medical Officer.
Essential Functions and Duties
• Formulate the medical aspects of drug development plans across multiple indications, from planning of first-in-human to Phase IV studies
• Design, plan, and direct the execution and completion of clinical trials of new or marketed products, within agreed upon timelines and budgets
• Prepare medical components of product plans, regulatory filings and corporate strategies
• Provide medical supervision of commercialization efforts
• Define and qualify unmet medical needs to set the strategy for positioning and clinical utility of our drug candidates with physicians, patients and payors
• Collaborate with key opinion leaders and other external experts in legal, policy and regulatory affairs; participate in conferences and scientific meetings to maintain awareness of research and related product activities
• Ensure that medical policies and protocols are in compliance with applicable regulations

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