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WHAT
IN
Director Sr Director Clinical Operations
Job
OSI Pharmaceuticals
US
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Ardsley,
New York
Job Code - AR00020
Position - See Job Description
Job First Active on: Monday, November 02, 2009
APPLY TO THIS JOB (You will be applying directly to OSI Pharmaceuticals for this position!)
JOB DESCRIPTION: Director Sr Director Clinical Operations
This position is responsible for all clinical operations activities, which involves all operational activities associated with clinical study initiation, execution including site monitoring and management. The responsibilit8ies also cover clinical study and vendor contract and budget negotiations, clinical study records management, and clinical SOP's. The selected individual will be responsible for the line management of Clinical Research personnel such as Clinical Program Managers and Clinical Research Associates responsible for the operational execution of oncology development clinical trials. This individual will work closely with the medical team in Clinical Development and with Biostatistics and Data Management as well as Medical Writing and Regulatory Affairs. The selected individual must be able to work under pressure and be able to work with multiple changing priorities.
REQUIREMENTS - QUALIFICATIONS: Director Sr Director Clinical Operations
- BS/BA is required, Masters or PhD preferred.
- Project/program management experience including a business/finance degree (MBA) is considered helpful.
- Requires a minimum of eight years in clinical research or life science environment, including at least 6 years relevant experience in clinical oncology operations activities in a pharmaceutical company. Previous formal supervisory/management responsibility is also required.
- Operational management of multiple clinical trials in an international environment Phases I-IV. Ideally, requires experience with IND/NDA submissions.
Has in-depth knowledge of drug development procedures both domestically and internationally and has extensive experience executing clinical oncology trials both using internal staff and third party vendors.
- Must have experience with finance/contract and document processing.
- Position may require up to 30% travel.
OSI Pharmaceuticals
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