Serves in a principal operational role for the Toxicology department, ensuring assigned department and project goals are achieved as assigned
Assists in defining standard departmental practices (including SOPs) for the conduct and reporting of Toxicology studies
Serves as the lead study monitor or sponsor representative with administrative oversight related to the conduct of Toxicology studies conducted at CRO
Collaborates with lead scientists providing direct input and suggestions on study designs and protocols
Responsible for independent coordination of study outsourcing (RFP, contracting, protocol development, monitoring, and reporting)
Provides detailed evaluation of experimental data from Toxicology studies and aligns with program toxicologists to interpret, report and present results
Assists/Directs the collection and evaluation of metrics associated with the conduct of Toxicology studies
Provides toxicology leadership assistance in regulatory inspection readiness activities

Bachelor’s or Master’s degree in biological sciences
more than 7 years of post-degree experience within a pharmaceutical/drug development environment
Significant experience in the design, monitoring and interpretation of regulated nonclinical safety studies
Knowledge of communicating Toxicology study results up to the level of global project teams
Ability to trouble-shoot challenges arising during the conduct of Toxicology studies

Manager – Toxicology Operations

Key skills