Distinguished Scientist, Safety Assessment Project Expert
Core
Oversight of nonclinical safety programs for R&D drug candidates, including strategy formulation, study design, and regulatory document authoring.
Role type
Distinguished Scientist, Safety Assessment Project Expert
Builds
Nonclinical safety strategies and regulatory submissions for small molecules, biotherapeutics, and oligonucleotides.
Domain
Pharmaceutical industry, nonclinical safety, toxicology, safety pharmacology.
Required skills
Toxicology, safety pharmacology, GLP compliance, ICH policies, regulatory submissions (IND/CTD), reproductive and developmental toxicity studies, scientific leadership, writing and presentation.
Preferred skills
GLP Study Director experience, ophthalmology toxicity studies, American Board of Toxicology certification.
Technologies
None stated.
Responsibilities
Serve as Preclinical Safety Project Team Member on multi-functional R&D teams; write nonclinical summaries for regulatory documents; ensure high scientific standards in study conduct and reporting; provide internal expertise on global nonclinical safety issues; participate in special projects or inter-industry working groups; provide scientific input on R&D activity design and in-licensing evaluations.
Seniority
Distinguished, strategic oversight with hands-on scientific leadership.