Scientist/ Study Director Toxicology - Preclinical CRO

Job Description

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.