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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2260070 |
| Location: Minneapolis, California |
Date Posted: 6/6/2008 |
| Wage: |
Category: Healthcare |
| Job Code: 5089698 |
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Job Description:
Responsibilities will include clinical development strategies, and execution of clinical programs including strategic planning, implementation, oversight and completion of each clinical research project. Responsibilities also include biostatistics, data management, medical monitoring, and medical writing.Position Requirements M.D. degree with Board Certification or Board Eligible and be recognized as having expert clinical knowledge in multiple disciplines. 5 to 10 years of relevant industry experience in either the pharmaceutical or biotechnology industries. Prior experience in a global clinical development capacity leading multi disciplinary teams is strongly desired with demonstrated capabilities to lead a clinical program to a successful filing and approval for a medical device in both the U.S. and European markets. Documented experience in leading a biostatistics and data management group strongly preferred. FDA panel presentation experience is a plus. Knowledge of FDAs Quality System Regulation 21 CFR Part 820, ISO 13485 2003, Council Directive 93/42/EEC (Medical Device Directive), and the Canadian Medical Devices Regulations; 1998. Knowledge of domestic and international regulatory requirements, clinical research methods, basic statistical procedures and budgetary management. Ability to design and conduct global clinical development programs. Ability to build a development organization and demonstrate operational expertise. Ability to effectively lead a Clinical Development organization by mobilizing the group to achieve successful outcomes. Ability to effectively manage a development budget of greater than 25 million dollars. Ability to demonstrate experience in conducting, designing, and/or serving as principal investigator for clinical trials; responsibility for more than one approved device is strongly preferred. Ability to write original scientific documents such as clinical summaries, PMA filings, investigator brochures, and internal reports. Ability to communicate effectively, orally and in writing, with many levels of employees of various disciplines within various departments.
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For further information, please visit us online at http://www.pharmaceuticalcrossing.com
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: PharmaceuticalCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: 91101 |
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Web Site: http://www.pharmaceuticalcrossing.com
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