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Toxicology External Study Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2298687 |
| Location: Raleigh, North Carolina |
Date Posted: 6/20/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5320461 |
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Job Description:
Acts as reference point for the SA Project Team Member (PTM) for General Toxicology aspects of a compound Accountable for all aspects of the conduct of all general toxicology studies associated with a compound at contract research organizations (CROs) to meet departmental and company-wide drug development timelines. Develops protocols in association with CRO Study Director, PTM and key contributing scientists Monitors study progress in a detailed manner and communicates ongoing study activities within COMPANY. Finalizes study reports in association with SA project team member and key contributing scientists Collaborates with CRO Study Directors, Worldwide Regulatory Compliance, DMPK scientists, SAPR, Peer Review Pathologists (PRPs) and scientists of other relevant disciplines to resolve expected and unexpected scientific, technical or quality issues. Acts as reference point for the CRO for the management and resolution of scientific items and in the context of initiatives such as the Building a Successful Partnership. Ensures consistency of study conduct and reporting among CROs and COMPANY SA sites. Ability to understand all scientific aspects of a compound and project for which specific studies are assigned Recognized competency in general toxicology with knowledge of animal husbandry, physiology and pharmacology in diverse experimental animals (including rodents, rabbits, dogs, and primates). Broad practical and conceptual ability in the design, conduct, data analysis and interpretation, and reporting of results from preclinical studies. Broad and integrated knowledge of all aspects of the specific discipline and associated processes including any appropriate regulatory guidelines. Demonstrated ability to apply expertise in leading and/or driving studies conducted at CROs with a track record of effective monitoring of a wide variety of general toxicology studies in multiple species at CROs. Knowledge and experience of Safety Policies, Good Laboratory Practices and relevant local and international regulations relating to the conduct of toxicology studies and the care and ethical treatment of experimental animals. Understanding of pharmaceutical industry drug development and CRO interactions. Understanding and appreciation of the role of a Study Director at a CRO Ability to conduct critical evaluations and generate creative options for scientific approaches making prudent decisions to achieve desired outcomes.
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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 |
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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.biotechcrossing.com
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