Distinguished Scientist, Safety Assessment Project Expert
Core
Lead nonclinical safety strategies and oversight for R&D drug candidates across the drug development value chain, ensuring safety, quality, and regulatory compliance.
Role type
Distinguished Scientist, Safety Assessment Project Expert
Builds
Nonclinical safety programs, regulatory documents (INDs, NDAs), and scientific strategies for small molecules, biotherapeutics, and oligonucleotides.
Domain
Pharmaceutical R&D / Toxicology / Safety Pharmacology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Nonclinical safety strategy design, toxicology study conduct and interpretation, regulatory document authoring (IND/CTA/NDA), GLP compliance, ICH policy knowledge, in-licensing safety risk assessment
Preferred skills
GLP Study Director experience, ophthalmology toxicity study expertise, American Board of Toxicology certification
Technologies
GLP, ICH guidelines, regulatory submission frameworks
Responsibilities
Formulate nonclinical safety strategies, design safety pharmacology and toxicology studies, author regulatory documents, provide scientific leadership in reproductive and developmental toxicity, review external laboratory reports, participate in inter-industry working groups
Seniority
Distinguished, strategic oversight & hands-on scientific leadership
