Director of Clinical Research Transcept Pharmaceuticals
THIS JOB HAS EXPIRED Job Description:Design, conduct and interpret data and results of pharmaceutical clinical trials. Provide medical, scientific and clinical support for Intermezzo clinical studies. Ensure that all clinical studies operate to the highest ethical and safety standards in compliance with regulatory requirements. Interpret results of phase 1-4 investigations in preparation for new drug applications and review and evaluate safety and efficacy data. Prepare for the clinical portions of new drug applications and license applications, including protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios. Provide tactical and strategic medical input to the discovery, development and commercialization of all of Transcept Pharmaceutical?s compounds. Interact with investigational sites, consultants and contract research organizations.
Doctor of Medicine (MD) or foreign equivalent medical degree plus 5 years of experience in the position offered or in a related clinical position.
Experience designing, conducting and analyzing phase I-III clinical studies.
Experience managing phase I-III clinical trials nationally and internationally.
Working knowledge of the drug development life cycle.
Experience in protocol development of Phase I-IV clinical trials and post-marketing .
Statistical knowledge of how to interpret study findings and communicate findings appropriately.
Working knowledge of regulatory procedures and guidelines both in the United States and Europe.
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Pt. Richmond, CA 94804
THIS JOB HAS EXPIRED