| | | Public San Francisco -Global Clinical Research -Oncology |
My Public San Francisco area client is focused on the development and commercialization of novel therapeutics for oncology.
This position in the overall management of the clinical project team and with the development of clinical plans and implementation of clinical trials.
Executive Director, Global Clinical Research and Development-Oncology
Essential functions include, but are not limited to the following:
• Oversee the implementation of clinical projects and the management of clinical studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
• Manage clinical personnel, including Clinical Project Managers, CRAs and contractors.
• Participate in strategic planning activities and the preparation of clinical development plans and budgets.
• Assist Regulatory Affairs in the preparation and review of U.S. and international regulatory filings.
• Assist in the recruitment of study centers and the development of strong working relationships with investigators.
• Participate in the designing of clinical studies, the development of protocols and the preparation of clinical and regulatory reports.
Experience:
• relevant Big Pharma Clinical research
• Boarded Oncology or Boarded eligible
• Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential.
• Demonstrated proficiency in the implementation, monitoring and management of clinical trials.
• Demonstrated management and/or supervisory skills.
• Broad knowledge and cross functional understanding of clinical trial methodology.
Education:
M.D., required. Training in Oncology.
Michael A. Terretti
Managing Director
Global Life Sciences
MRI-Raleigh
919-781-0400x112 office
mterretti@mriraleigh.com | | More |
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