Senior Scientist, Safety Assessment
Core
Design, execute, and interpret nonclinical safety studies for IND-enabling gene editing therapeutics, with a focus on liver-targeted programs.
Role type
Senior Scientist, Nonclinical Safety Assessment
Builds
Safety data and reports for regulatory submissions of gene editing therapies
Domain
Biotechnology / Gene Editing / Toxicology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
nonclinical safety assessment, assay execution and troubleshooting, GLP study oversight, toxicology data interpretation, regulatory guideline compliance, cross-functional collaboration
Preferred skills
large molecule therapeutic development, immunology background, CRO study support
Technologies
gene editing platforms, lipid and RNA components
Responsibilities
Design, execute, and troubleshoot nonclinical safety studies including hands-on laboratory work; Support execution and oversight of studies at CROs; Analyze and interpret study data for regulatory reports; Collaborate with Pharmacology and DMPK on exploratory studies; Evaluate new delivery approaches and emerging targets; Ensure compliance with regulatory guidelines.
Seniority
Senior, hands-on IC