US-NJ: West New York-Director Clinical Research
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US-NJ: West New York-Director Clinical Research         

Group: aol.neighborhood.nj.jerseycity · Group Profile
Author: JobCircle.Com
Date: Jul 24, 2008 14:20

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Job Title: Director Clinical Research
Job Location: NJ: West New York
Pay Rate: Open
Job Length: full time
Start Date: 2008-07-24

Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856

Description: Director, Cardio Metabolic, Clinical Development Group



Primary responsibilities for this position would be for clinical activities related to the support and commercialization of approved cardio metabolic assets including development, design, and execution of Phase IV studies as well as provision of marketing support to commercial groups. Additional responsibilities would include Phase II and III Clinical Development activities as the need arises. In-licensing support includes medical/scientific evaluation of opportunities and use of consultant resources to provide sound advice to upper management in area of clinical expertise. Medical Affairs activities to include development and design of Phase IV studies as well as provision of marketing support to commercial groups are primary. Phase II and Phase III support as the need arises is secondary. In-licensing support includes medical/scientific evaluation of opportunities and use of consultant resources to provide sound advice to upper management in area of clinical expertise; because the group also conducts studies for NDA/BLA approval, experience in drug development will also provide the candidate with the potential for additional versatility within the group. Duties include: supervision, direct involvement with, and approval of all clinical documents, synopses, protocols, clinical reports, briefing documents, summary documents, regulatory documents, direct responsibility for, including medical monitoring of, clinical studies, direct involvement in study-related meetings, both internal and external, provide medical, therapeutic, and disease expertise for development programs and evaluation of in-licensing candidates, provide support and advice to marketing for commercialization of the product, review of product related marketing documents, identify and develop contacts with external consultants and opinion leaders to ensure strong reputation in the community as well as liaison responsibilities with partner company; may have two (2) or more direct reports. The ideal candidate will have the following skills and experiences: medical degree plus expertise in cardiovascular medical affairs, US subspecialty Board eligible, at least 2 years of direct clinical experience (patient contact) in the US, candidate should have approximately 3 to 4 years of drug development experience, with an emphasis on Phase IV programs. At least 2 of these years should have taken place within the pharmaceutical industry, proven ability to develop and implement highly successful clinical strategies and programs, strong negotiation and influencing skills, proven leadership abilities and a track record of directing clinical teams in a matrix environment to ensure consistently high standards of attainment of project and study milestones, maintain awareness and understanding of emerging trends in disease management concepts, clinical development, regulatory affairs, and market needs, and their impact and experience in drug development will provide the candidate with the potential for additional versatility within the group

Please refer to Job code TP5750 when responding to this ad.

For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/1556766.html?source=ng to apply online.

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