Director, Toxicology

Role Summary

The Director, Toxicology will play a critical role in supporting the nonclinical safety assessment of therapeutics within Denali's pipeline. This position involves conducting and managing toxicology studies, analyzing and interpreting safety data, and collaborating with cross-functional teams to advance drug candidates through various stages of development.

Responsibilities

• Design and implement nonclinical toxicology programs and strategies to evaluate the safety of Denali's 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, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.

Education

• PhD in Toxicology, Biology, Pharmacology or related scientific discipline

Qualifications

• 7+ years of industry (biotech/pharmaceutical drug discovery/development) and/or related experience required; 5+ years of people management/coaching/mentorship required
• 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 demonstrated can-do attitude
• Ability to work in a fast-paced environment
• Excellent oral, presentation, and written communication skills