Senior Scientist Drug Safety & Metabolism
Core
Design, coordinate, monitor, and report in vivo safety studies for veterinary small molecule pharmaceuticals to support regulatory approval.
Role type
Senior Scientist Drug Safety & Metabolism (Preclinical Development)
Builds
Regulatory submission packages for veterinary pharmaceuticals
Domain
Veterinary pharmaceuticals / Preclinical safety
Required skills
In vivo safety study design, GLP compliance, CRO management, raw data review, regulatory reporting, toxicology/pharmacology knowledge, bioanalytical techniques, tissue culture, flow cytometry, immunohistochemistry
Preferred skills
Residue study experience, electronic data capture systems, international regulatory guidance knowledge
Technologies
Microsoft Office Suite, SharePoint, Electronic Data Capture systems
Responsibilities
Design study protocols and data capture forms, monitor CRO compliance with GLP regulations, review raw data and study reports for quality/integrity, prepare submission-ready packages for global health authorities, coordinate study timelines and resources
Seniority
Senior, hands-on IC