Associate Director, Non-clinical Drug Safety

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the toxicology subject matter expert within cross-functional discovery and development teams.

• Offer strategic nonclinical safety guidance to facilitate program advancement and decision-making in development.

• Lead and supervise IND and NDA enabling GLP toxicology studies.

• Review, analyze, and interpret scientific data and outcomes from toxicology studies.

• Incorporate findings into comprehensive nonclinical safety evaluations and development strategies.

• Oversee outsourcing and study-related activities, including study timelines, budgets, and deliverables for assigned projects.

• Communicate toxicology insights and risk evaluations to project teams and senior management.

• Influence program decisions with scientifically sound and risk-informed recommendations.

• Serve as author/co-author and reviewer of regulatory documents.

• Collaborate with the nonclinical team to adapt to new guidance requirements.

• Analyze competitive scientific intelligence from external resources.

• Contribute to initiatives aimed at continuous improvement and the implementation of evolving regulatory guidance within Nonclinical Drug Safety.

⛳️ Requirements

• MSc or PhD in Toxicology, Pharmacology, or related fields, with a minimum of 7 years of experience in a pharmaceutical company or contract research organization.

• Diplomate of the American Board of Toxicology (DABT) is highly preferred.

• Strong preference for experience in Biologics.

• Robust technical experience in planning and executing nonclinical studies.

• Comprehensive understanding of regulatory requirements and the overall drug development process.

• Regulatory expertise is preferred, including successful IND/CTA submissions.

• Ability to adapt to changing business needs and manage multiple programs concurrently.

• Detail-oriented with excellent written and verbal communication abilities.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-provided basic life insurance, as well as accidental death and dismemberment coverage.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• A generous 401(k) matching program.

• Flexible time off policies.

• Paid holidays.

• Paid leave programs and additional company-provided benefits.