Associate Director, Toxicology

Role Summary

Associate Director, Toxicology responsible for driving nonclinical safety assessment of small and large molecule therapeutics, conducting and managing toxicology studies, analyzing safety data, and collaborating with cross-functional teams to advance drug candidates. Serves as a functional leader for the Toxicology team with people leadership accountability for one or more Toxicologists.

Responsibilities

• Design and implement nonclinical toxicology programs and strategies to evaluate the safety of therapeutic candidates.
• Conduct and oversee non-GLP and GLP toxicology studies, ensuring adherence to regulatory standards.
• Analyze, interpret, and summarize toxicology data to support safety evaluations.
• Prepare and present safety data to internal project teams and senior management, contributing to informed decision-making.
• Assist in the preparation and authoring of regulatory documents related to nonclinical safety assessments.
• Ensure compliance with relevant regulatory guidelines and standards throughout all stages of toxicology studies.
• Work closely with colleagues in Research and Development, providing toxicology expertise to support cross-functional project teams.
• Participate in project meetings, offering insights and recommendations to advance safety assessment strategies.
• Support investigative efforts into mechanisms of toxicity and contribute to the development of safer therapeutic candidates.
• Assist in developing and implementing de-risking strategies for drug discovery and development projects.
• Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, and training compliance, providing ongoing feedback on growth and development.

Qualifications

• PhD or advanced degree in Toxicology, Biology, Pharmacology, or related scientific discipline.
• Approximately 7+ years of relevant work experience (including postdoctoral work) or MS with 10+ years of relevant experience.
• Experience with biologics and oligonucleotides preferred.
• Strong scientific background and scientific aptitude.
• Excellent critical thinking and scientific skills.
• Ability to work effectively and collaboratively on cross-functional project teams and a can-do attitude.
• Ability to work in a fast-paced environment.
• Excellent oral, presentation, and written communication skills.