Vice President, Worldwide Clinical Development The Vice President, Worldwide Clinical Development for this Bay Area client will be responsible for all aspects of gene therapy clinical research programs worldwide. This will include planning, implementation, coordination and completion of each research project according to FDA regulations and internal policies and procedures and within the bounds of good scientific and ethical conduct. The Vice President will assure that all pre-clinical and clinical studies are conducted according to protocol and that data reported is accurate and will be acceptable to any internal or external auditing body. This individual will be responsible for medical writing functions in support of medical reports, registration dossiers and manuscripts. The successful candidate will have an M.D. with specialty focus in either Oncology or Cardiology. Ideally, the successful candidate will be Board Certified in one of the above fields. He or she will have approximately ten years of clinical research experience in the pharmaceutical or biotechnology industry with responsibility for directing a staff. Experience in gene therapy clinical research is preferred. This individual must be knowledgeable in FDA regulations and international regulatory requirements, clinical research methods, basic statistical procedures and budgetary management. [ back ]
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