Senior Toxicologist, Non-Clinical Pharmacology Scientist
Core
Define and manage Toxicology and Non-Clinical Pharmacology strategies for preclinical projects to support Clinical and Core Asset Teams for products under development or geographic expansion.
Role type
Senior IC non-clinical pharmacologist/toxicologist
Builds
Preclinical safety studies and regulatory documentation for rare disease therapies
Domain
Biopharmaceuticals / Rare diseases
Required skills
Toxicology strategy, Non-clinical pharmacology, Regulatory toxicology, Drug development lifecycle, Impurity assessment, Preclinical study management, Translational medicine integration, Scientific communication
Preferred skills
Biologics, Small molecules, Oligonucleotides, Gene therapy, Combination drugs, Immunotoxicology, Board certification (DABT/ERT)
Technologies
Contract Research Organizations (CROs), Regulatory documents (IB, IND summaries, IMPD, RMP)
Responsibilities
Define Toxicology and Non-Clinical Pharmacology strategies, Manage preclinical safety studies in CROs, Interact with regulatory authorities, Perform Toxicology assessments for impurities, Participate in scientific communications
Seniority
Senior, hands-on IC
