Senior Scientist, Toxicology I
Core
Function as GLP Study Director for internal toxicology studies and external sponsor monitor for CRO-conducted studies, ensuring regulatory compliance and report authorship for drug submissions.
Role type
Senior Scientist, Toxicology (GLP Study Director)
Builds
Toxicology study reports and regulatory filing documents for drugs in development
Domain
Pharmaceutical toxicology and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> research
Required skills
GLP study design and conduct, toxicology report authorship, regulatory compliance (FDA/ICH/OECD), scientific expert judgment, project timeline management, data interpretation and tabulation
Preferred skills
PhD in Toxicology or related field, post-doctoral training, toxicology study director experience in pharma or CRO
Technologies
GLP compliance frameworks, regulatory filing systems
Responsibilities
Ensure highest standards in quality and regulatory compliance for study conduct and reporting; author and review toxicology study reports and prepare components of filing documents; serve as scientific expert during audits and on project teams; manage study timelines against regulatory filing needs; design, conduct, and report toxicology studies aligned with development plans; interpret experiments and record/report results and significant issues.
Seniority
Senior, hands-on IC
