Executive Director, Toxicology
$285k - $405.5kExelixis Inc
Executive Director leading a toxicology team to develop nonclinical safety strategies for small and large molecule drug programs across discovery through regulatory submission. Responsible for establishing scientific standards, managing cross-functional partnerships, and overseeing GLP and investigative studies to support clinical development and global approvals.
Responsibilities
- Lead toxicology strategy for small molecule and biotherapeutic programs from discovery through registration
- Define integrated nonclinical safety and pharmacokinetic strategies supporting candidate selection and regulatory submissions
- Oversee design, conduct, and interpretation of GLP and investigative toxicology studies with internal teams and CROs
- Author and defend nonclinical sections of regulatory documents including INDs, CTAs, NDAs, and BLAs
- Build organizational capability through succession planning, talent development, and scientific culture creation
Requirements
- PhD in Toxicology, Pharmacology, Pathology, DVM or related field with 15+ years relevant experience
- Extensive experience leading toxicology and nonclinical safety activities in biotech or pharma
- Experience managing CROs, external partners, and cross-functional teams
- Comprehensive knowledge of nonclinical safety, GLP regulations, and drug development pathways
- Advanced leadership, communication, and analytical problem-solving skills
- Ability to operate effectively in complex matrix environments and influence senior leaders
- DABT or equivalent board certification preferred
Compensation: $285,000-$405,500 base annually
Vacancy posted a month ago
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