Job Description
Senior Study Director/ Toxicologist
We are a growing mid-size organization with multiple sites looking for an accomplished Senior Study Director for our Toxicology division to assist with the growth we are experiencing and have plans to continue.
Say Goodbye to the bureaucracy and the administrative aspects of large cumbersome organizations and say Hello to the Science!
As a Senior Study Director, you will be responsible for participating in the design of non-clinical / preclinical studies as well as providing the scientific oversight of the study.
These studies will involve standard laboratory animal species (mice, rats, NHP, swine) across typical test article types (Vaccines, Biopharmaceuticals, Small Molecules).
This role will encompass multiple site studies and coordination thereof.
Maintaining and completing multiple projects simultaneously
Developing Protocols
Communicating with staff, management, and clients/sponsors
Analysis, interpretation, and reporting of data from non-clinical studies.
Manage the conduct of study activities in compliance with the protocol, amendments, and facility SOPs
May also assist in the further development of SOPs, training materials, and policies.
Proactive recognition, documentation, and resolution of any issues affecting the conduct of non-clinical studies.
Maintain knowledge of FDA and other regulatory guidelines
Work with the appropriate individuals to design and approve the study protocols
Perform other duties directed by the Director of Toxicology to meet client needs.
Experience, Education, and Specialized Knowledge and Skills:
Education
At least 5 years of experience directing non-clinical in vivo studies at a CRO or Pharmaceutical Company with a BS
-or-
At least 2 years of relevant industry/ toxicology experience with an MS or Ph.D./DVM
DABT or board eligible preferred
Demonstrated expertise in a scientific discipline
Essential Skills include: leadership, good organizational skills, knowledge of an experience with GLP (Good Laboratory Practices), AAALAC and USDA guidelines, experience using computer applications.
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