Principal Toxicologist-Scientist
Core
Provide scientific leadership for safety assessment of Genentech therapeutics across drug development, integrating toxicology, pathology, and pharmacology to identify risks and shape development strategy.
Role type
Principal Scientist (Toxicology)
Builds
Safety assessment strategies and GLP/non-GLP safety programs for novel modalities and accelerated regulatory strategies
Domain
Pharmaceutical/Biotechnology, Oncology and non-oncology therapies
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
toxicology, pathology, pharmacology, translational science, clinical information synthesis, risk assessment, study design, regulatory document authoring, weight-of-evidence synthesis
Preferred skills
oncology therapy experience, novel modalities (small molecules, biologics, ADCs, cell and gene therapy), regulatory authority interaction, new approach methodologies (NAMs), animal use reduction
Technologies
GLP, non-GLP, NAMs
Responsibilities
Design and implement safety assessment strategies; partner with pathologists and study operations to design fit-for-purpose safety programs; synthesize complex datasets to support risk assessment and dose selection; anticipate safety issues and lead mechanistic studies; manage safety liabilities and communicate impact; author regulatory documents and present to health authorities; advance external scientific standing through publications and collaborations.
Seniority
Principal, hands-on IC with strategic leadership