Executive Director, Toxicology & Nonclinical Safety

Exelixis; Alameda (CA); On-site; USD 285,000 - 406,000; Full time

Benefits offered by this job

401k plan with company contributions

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock purchase plan

PTO, holidays and sick days

Job summary

Exelixis in Alameda, CA seeks an Executive Director, Toxicology to lead a team of toxicologists and set the scientific vision, standards and operating model for nonclinical safety across the portfolio.

You will define integrated safety strategies for small molecules and biologics, oversee GLP/non-GLP studies, manage CROs and external partners, and partner with cross-functional teams to drive regulatory submissions and risk-based decision-making.

Qualifications

• Extensive leadership of toxicology, nonclinical safety and safety pharmacology in biotech/pharma.
• Experience supporting discovery through global regulatory submissions (IND/CTA/NDAs/BLAs).
• Proven CRO management, external partners and cross-functional team leadership.

Responsibilities

• Lead Toxicology strategy for small molecule and biotherapeutic programs from discovery through registration.
• Define integrated nonclinical safety, safety pharmacology, toxicokinetic and drug metabolism strategies.
• Oversee design, conduct, monitoring and reporting of GLP and non-GLP studies; ensure data integrity.
• Represent Toxicology in project teams and communicate risk assessments to senior leadership.
• Author/defend nonclinical sections of regulatory documents and submissions.
• Partner across functions to drive integrated development plans and risk-based decisions.
• Manage CRO/external relationships; ensure timelines, budgets and quality.
• Identify safety issues and develop de-risking strategies for portfolio progression.
• Develop resource plans, budgets and scalable processes to support portfolio needs.
• Drive external scientific visibility via publications and partnerships.
• Build leadership pipelines and a high-performing scientific culture.
• Perform other duties as assigned; comply with policies.

Skills

Leadership

Strategic thinking

Communication

Cross-functional leadership

Regulatory experience

Education

PhD in Toxicology or related

DABT certification

15+ years experience

Job description

Exelixis in Alameda, CA seeks an Executive Director, Toxicology to lead a team of toxicologists and set the scientific vision, standards and operating model for nonclinical safety across the portfolio.

You will define integrated safety strategies for small molecules and biologics, oversee GLP/non-GLP studies, manage CROs and external partners, and partner with cross-functional teams to drive regulatory submissions and risk-based decision-making.