Vice President of Clinical Affairs

Abiomed in Danvers, MA

  • Industry: Engineering - Biological And Biomedical Engineer
  • Type: Full Time
position filled
Provide Strategic leadership for the design and execution of clinical studies on a global basis to achieve optimal speed, quality and economy. Direct the development of protocols and government documents and the sponsoring and execution of clinical studies in compliance with pertinent regulations. Participate in the review of regulatory submissions for product approvals. Provide input on the strategic formulation of protocols. Direct the work of clinical investigators to prepare publications, presentations, etc. of study findings. Interface with government agencies on product application and compliance. Subject Matter Expert to the management team, sales force and others regarding Abiomed’s clinical research, leading to physician adoption and real-world practical use. Attend seminars and meetings as Abiomed’s SME. Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations. DESIRED QUALIFICATIONS: MD in cardiology, preferably with expertise in interventional cardiology and/or heart failure. 12+ years of experience directly supporting clinical research or similar experience in medical device Must have 8+ years of managerial experience with demonstrated success in organizational development, leadership, and budgetary responsibility. Advanced knowledge of medical terminology and knowledge of clinical and outcomes research study design in addition to expertise with GCP (Good Clinical Practices) and regulatory compliance guidelines for clinical trials. Demonstrated success in developing complex clinical affairs strategies across multiple product lines across multiple multi-national geographies. Ability to travel internationally up to 40%

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