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Senior Study Director (DART)  Maryland

Join a dynamic, publicly held company supporting the pharmaceutical and biotechnology industries with informatic solutions, integrated contract research services and drug repositioning solutions.  Operating three Strategic Business Units enhances diversification and stability.   Our client company offers a competitive compensation package with incentives and stock options plus comprehensive benefits including medical, dental, paid-time-off, etc.

In this HIGHLY VISIBILE position, you will serve as the technical Project Manager for in-house Developmental and Reproductive Toxicology studies and will be the primary point of contact with clients to deliver quality projects on time.

Responsibilities:  Overall study oversight and management including technical conduct of the study, interpretation, documentation and reporting of results. Primary point of contact with Sponsor on all study related issues. Prepare study protocols and amendments, obtain appropriate signatures, and arrange for distribution and QA audit, if required. Submit IACUC review form. Arrange for the required amount of test articles to be delivered. In accordance with the SOPs, review and approve study events, i.e., animal orders, formulation procedures, randomization, and any specialized data collection forms. Arrange and conduct study pre-initiation meeting. Periodically observe animals, critical phases and review study data for scientific quality, animal welfare and compliance with protocol, SOPs and applicable regulations. Monitor study budget and time line. Respond to QA audits. Oversee reporting writing process, receiving and addressing client comments, interacting with contributing scientists, and approving the final report. Work closely with clients and Business Development to create repeat and/or new business opportunities.

Requirements: Advanced degree in toxicology or related field, and relevant experience with at least 3 years of contract toxicology experience. Experience in DART, expertise in toxicology, reproductive toxicology, immunology, pharmacology and/or related fields; DABT or working toward certification. Excellent computer, communication and writing skills.  If fully qualified, please reply in confidence to Julie@advantage-search.com with your resume attached as an MS Word doc.

 

 

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