Sr. Principal Scientist, Nonclinical Drug Safety
Core
Senior scientific leader responsible for advancing nonclinical drug safety strategies, risk assessments, and regulatory submissions for Immunology therapeutic area programs.
Role type
Principal Scientist, Nonclinical Drug Safety (Therapeutic Area Leader)
Builds
Nonclinical development programs, regulatory documentation (INDs, NDAs, BLAs), and risk assessments for Immunology candidates.
Domain
Pharmaceutical / Biotechnology / Immunology / Nonclinical Drug Safety
Required skills
Toxicology, Immunology, Pharmacology, Pathology, Regulatory Strategy, Risk Assessment, GLP Compliance, Strategic Planning, Mentorship, Scientific Writing
Preferred skills
Immuno-oncology experience, Multi-modality development, Global regulatory strategy, Cross-industry collaboration
Technologies
Omics Technologies, Cell Line Engineering, Pharmacodynamics, Pharmacokinetics
Responsibilities
Oversee nonclinical development programs and post-marketing support for Immunology; deliver high-quality risk assessments and regulatory submissions; provide scientific oversight and mentorship to Compound Leaders; collaborate with R&D functions on program design and toxicology studies; contribute to global nonclinical strategy through publications and collaborations.
Seniority
Principal, Strategy & Mentorship