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Company:
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Gman Business Resources |
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Job Title:
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Medical Director |
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Job Category:
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Healthcare/Medical |
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Job description:
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The Medical Director is primarily responsible for ensuring the safety of clinical trials. The Medical Director is also responsible for directing medical functions of the department, clinical development, new approvals, regulatory reports and peer-reviewed manuscripts based on Clinical Studies of the division. Participates on division strategic teams including the identification of new indications for existing licensed products.
Strategically supports clinical trials throughout the evolution of clinical trial design, execution and completion of the study, providing medical and technical support. Incumbent will provide medical technical perspective to the Business Development and Portfolio Management functions in the identification of potential partnering and internal opportunities. Shares medical expertise with his/her counterparts in other functional areas such as Manufacturing, Quality, Assurance, Regulatory Affairs, R&D, Legal and Marketing globally, ide input into clinical research strategy and conduct clinical trials for unlicensed products and optimize new product development for successful launch into the marketplace.
1) Review all reported adverse events in clinical trials of investigational products. Assess, query and recommend corrections to MedDRA coding of adverse events. Approve MedDRA coding of adverse events.
2) Support and contribute to overall clinical research strategy, safety and conduct of clinical trials of products and/or new indication for a licensed product.
3) Provide strategic leadership to the department activities related to the evaluation and reporting of issues and adverse events related to products safety and efficacy, as well as strategies and activities associated with technical support for divisional products in the global clinical market.
4) Provide medical and scientific direction on clinical matters affecting preparation and submission of timely and sound information to the global regulatory agencies.
5) Work with product development and marketing functions to define the requirements and specifications for new products.
6) Maintain knowledge base as to developments and trends in medical science pertaining to his/her area of responsibility.
7) Contribute to the training, leadership and continuing education for all of Clinical R&D.
8) Participate in the development and writing of Clinical Trial Protocols. Provide input to investigator’s brochure and interim/final CSR’s. Approve final clinical trial protocols, investigator’s brochures and clinical study reports.
9) Serve as expert consultant to quality and medical vigilance functions in the investigation of adverse events and other product related issues. Assist as requested in the preparation of periodic and other regulatory reports. |
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Skills:
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MD degree with active medical licensure in at least one country
Since 60% of this position is involved in clinical study development, this individual must be proficient in all aspects of study design principles.
At least 10 years experience after completion of residency; at least three which involve clinical activities; four years industry experience.
Medical coding and classification and reporting of AEs and SAEs is required
Must be fluent in both spoken and written English. |
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Language requirements:
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Employment type:
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Salary Range:
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190000 USD |
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| Other Information |
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Degree:
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Doctorate |
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Experience (year):
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10 |
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Job Location:
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Westlake Village - California - USA |
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Post Date:
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11/28/2006 |
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| Contact Information |
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Company:
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Gman Business Resources |
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Contact Name:
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Gman Business Resources |
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Contact Email:
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george@gmansearch.com |
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Contact Phone:
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6412367910 |
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Contact Fax:
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6412367912 |
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