Global Director, Toxicology & Nonclinical Strategy

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

Benefits offered by this job

401k plan

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock purchase and long-term incentive

Paid vacation and holidays

Job summary

Exelixis seeks an Executive Director, Toxicology to lead a team of toxicologists and shape nonclinical safety strategies across discovery to regulatory submission. The role partners with multiple disciplines to drive integrated development plans and ensure high-quality outputs.

You will manage CRO relationships, mentor scientific leaders, and represent Toxicology in governance and regulatory meetings, with a focus on scalable processes and portfolio growth.

Qualifications

• PhD in Toxicology, Pharmacology, Pathology, DVM or related discipline with 15+ years of relevant experience; or an equivalent combination.
• DABT or equivalent board certification preferred.
• Extensive experience leading toxicology, nonclinical safety and safety pharmacology activities in biotech/pharma.

Responsibilities

• Lead Toxicology strategy for small molecule and biologics programs from discovery through registration.
• Define integrated nonclinical safety, safety pharmacology, toxicokinetic and drug metabolism strategies.
• Oversee GLP and non-GLP toxicology studies and CRO partnerships.
• Represent Toxicology in project teams and communicate risk assessments to senior leadership.
• Author and defend nonclinical sections of regulatory documents (INDs, CTAs, NDAs, etc.).
• Manage CROs and external partners to ensure quality, timelines and budgets.

Skills

Toxicology leadership

Nonclinical safety

Regulatory submissions

CRO management

Cross-functional leadership

GLP compliance

Project management

Education

PhD in Toxicology

DABT certification preferred

Job description

Exelixis seeks an Executive Director, Toxicology to lead a team of toxicologists and shape nonclinical safety strategies across discovery to regulatory submission. The role partners with multiple disciplines to drive integrated development plans and ensure high-quality outputs.

You will manage CRO relationships, mentor scientific leaders, and represent Toxicology in governance and regulatory meetings, with a focus on scalable processes and portfolio growth.