Description

• Serve as the toxicology subject matter expert on cross-functional discovery and development teams and provide strategic nonclinical safety recommendations to support program progression and development decision-making
• Lead and oversee IND and NDA enabling GLP toxicology studies
• Review, analyze and interpret scientific data and results for toxicology studies and integrate findings into overall nonclinical safety assessments and development strategies
• Manage outsourcing and study activities, study timelines, budgets, and deliverables for assigned programs
• Communicate toxicology findings and risk assessments to project teams and senior leadership, influencing program decisions through scientifically sound and risk-based recommendations
• Act as author/co-author and reviewer of regulatory documents
• Collaborate within the nonclinical team to incorporate new guidance requirements
• Analyze competitive scientific knowledge from external sources
• Contribute to continuous improvement initiatives, scientific standards, and implementation of evolving regulatory guidance within Nonclinical Drug Safety

Requirements

• MSc or PhD in Toxicology, Pharmacology or related areas with at least 7 years of experience in a pharmaceutical company or contract research organization
• Diplomate of the American Board of Toxicology (DABT) is highly desired.
• Strong preference to experience in Biologics
• Strong technical experience in planning and executing nonclinical studies
• Thorough knowledge of regulatory requirements and the overall drug development process
• Regulatory expertise preferred, including successful IND/CTA submissions
• Ability to switch tasks and priorities as business needs change and manage multiple programs simultaneously
• Detail-oriented with strong written and verbal communication skills