Senior Director, Pharma Toxicology
Core
Provide enterprise-wide leadership for nonclinical safety across a diverse pharmaceutical, over-the-counter, and consumer health portfolio, defining global toxicology direction and ensuring development programs meet scientific and regulatory standards.
Role type
Senior Director, Pharma Toxicology (Strategy & Leadership)
Builds
Global nonclinical safety strategy, regulatory submissions, and innovative healthcare products
Domain
Pharmaceutical industry + Nonclinical Toxicology
Required skills
Global nonclinical safety strategy, FDA and global health authority interaction, nonclinical regulatory requirements (ICH, GLP), CRO and vendor management, team building and scaling, scientific risk assessment, cross-functional collaboration
Preferred skills
Ophthalmology drug development experience, Diplomate of the American Board of Toxicology (DABT) certification
Technologies
ICH guidelines, GLP regulations, New Approach Methodologies
Responsibilities
Define global nonclinical safety and toxicology strategy; Serve as senior toxicology expert for regulatory milestones (pre-IND, IND, NDA/MAA); Lead nonclinical due diligence for licensing and acquisitions; Monitor emerging regulatory guidance and drive adoption of alternatives to animal testing; Build and develop a high-performing toxicology team; Manage strategic relationships with CROs and external experts; Direct design and execution of nonclinical safety programs; Provide final scientific review of regulatory submission sections; Partner with senior leaders across Product Development, Clinical, Regulatory, and Commercial teams.
Seniority
Senior Director, Strategy & Leadership