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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