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
Sr. Principal Scientist, Nonclinical Drug Safety (Therapeutic Area Leader)
Builds
Nonclinical development programs, regulatory documentation, and post-marketing support for Immunology candidates
Domain
Pharmaceutical drug development, Nonclinical Drug Safety, Immunology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Toxicology, Immunology, Pharmacology, Pathology, Regulatory Processes, ICH Guidelines, GLP Requirements, Nonclinical Risk Assessments, Drug Development Strategy, Scientific Publications, Cross-functional Leadership
Preferred skills
Immuno-oncology drug development, Multiple therapeutic modalities, Global regulatory strategy influence, Product registration (BLA/WMA)
Technologies
Cell Line Engineering, Omics Technologies, Pharmacodynamics, Pharmacokinetics
Responsibilities
Oversee progression of nonclinical development programs and post-marketing support for Immunology; Deliver high-quality nonclinical strategies and regulatory submissions; Provide scientific oversight and mentorship to Compound Leaders and Program Coordinators; Identify program issues and guide resolution through ambiguity; Author and review nonclinical sections of regulatory documents (INDs, NDAs, BLAs, etc.); Collaborate on emerging discovery projects and contribute to global nonclinical development strategy.
Seniority
Principal, strategic leadership & mentorship
