Job Purpose

This newly created position will contribute to all phases of monitoring and oversight of Contract Research Organization (CRO) conducted toxicology studies (GLP and Non-GLP). In addition, it will also be responsible for operations for non-clinical development including ownership of process related deliverables, review of non-clinical sections of worldwide regulatory submissions, and project management of non-clinical development projects.

Key Responsibilities

Contracting activities including price and contract negotiations, purchase requisitions and processing of invoices and CRO scheduling and timeline updates.
Coordinating test article supply and tracking stability testing to support each toxicology study
Scientific oversight of non-clinical toxicology studies including protocol review/preparation and study monitoring
Data and slide preparation for internal discussions and/or presentations as well as compiling and QC of non-clinical data tables for regulatory submission
Writing and reviewing non-clinical sections of regulatory submissions
Project management to ensure the delivery of timelines and milestones

Requirements

Strong independent analytical and problem-solving capabilities, displaying creativity and innovation
Familiar and experienced with the oversight of GLP compliant non-clinical development to support pharmaceutical and biologic drug development and have knowledge of non-clinical regulatory requirements
Excellent oral and written communication skills as well as strong organizational skills and have the ability to work efficiently

Education:

BS, MS or PhD degree in a biological science or related field.

Experience:
A minimum of 3 or 5 years of experience conducting and/or monitoring GLP compliant toxicology studies in a biotech/pharma environment