Senior Toxicologist
Core
Lead nonclinical development programs by designing, conducting, and interpreting regulatory toxicology and exploratory pharmacology studies in rodent and non-rodent safety models to support global R&D projects.
Role type
Senior IC toxicologist
Builds
Non-clinical safety assessment strategies and regulatory submission packages for pharmaceutical products
Domain
Pharmaceutical industry, non-clinical safety, regulatory toxicology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GLP regulations, FDA/EMEA/ICH guidelines, study design, data interpretation, regulatory documentation authorship, cross-functional team leadership, budget management, contract research organization coordination
Preferred skills
Therapeutic modalities (antibody, oligonucleotide, genetherapy), advanced degree in pharmacology/toxicology/biological science
Technologies
GLP, FDA, EMEA, ICH frameworks
Responsibilities
Represent toxicology on global R&D project teams, coordinate cross-department execution of experimental plans, manage toxicology studies at contract research organizations, communicate study findings to project teams, contribute to IND and NDA submissions, maintain currency with safety guidelines
Seniority
Senior, hands-on IC