Director, Clinical Research Job

Employer Name: BiotechCrossing	SpiderID: 2350517
Location: Memphis, Tennessee	Date Posted: 7/8/2008
Wage:	Category: Biotech
Job Code: 6087191

Job Description:
Directly responsible for multiple clinical research programs regarding Medtronic medical products. * Provide overall global direction for the design & conduct of all clinical studies for current and new venture products and therapies. * Ensure the development & implementation of global clinical programs to achieve global regulatory approvals for new venture products. * Review clinical submissions for product approvals such as Investigational Device Exemptions (IDE), Investigational New Drug (IND), Biologics and appropriate final approvals. Prepares or assists in the preparation of these documents. * Participate on product development teams to influence product design & determine pre-clinical & clinical testing requirements. * Insure operational efficiencies within the department to incorporate clinical quality and training. * Manage personnel and the execution of clinical studies on a global basis. Includes the development of protocols and government documents and the sponsoring and execution of clinical studies in compliance with corresponding regulations. * Direct the design of clinical trial protocols in accordance with statistical methods to insure the integrity of study results. * Manage or collaborate on the international research process of those products needing human clinical studies. * Interface with government agencies on product application and compliance issues; * Scrutinize the legislative and regulatory process identifying significant threats or opportunities. * Develop solid relationships with clinical investigators to insure adequate support is available in the management of clinical research, publications, presentations, etc. * Prepare budget recommendations and monitor program finances.

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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: BiotechCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.biotechcrossing.com