Leads nonclinical safety strategy for development programs, advancing assets from discovery through clinical stages. Shapes toxicology approaches, interprets complex data, and influences program decisions to ensure patient safety and regulatory success. Serves as a scientific authority in toxicology, integrating cross-functional insights and external regulatory expectations. Drives innovation in safety assessment while contributing to organizational scientific leadership.
Key Accountabilities/Core Job Responsibilities:
Develop and lead nonclinical toxicology strategies for multiple programs across discovery and development stages
Interpret toxicology and safety pharmacology data to inform risk assessment and program decisions
Provide strategic input into regulatory submissions, including IND-enabling studies and health authority interactions
Influence cross-functional teams by integrating toxicology insights with clinical, regulatory, and translational considerations
Oversee design, execution, and interpretation of outsourced and internal toxicology studies
Identify and mitigate safety risks, proposing alternative strategies to advance programs
Contribute to governance discussions, representing toxicology perspectives in decision-making forums
Build external scientific network and monitor emerging trends in toxicology and safety sciences
Mentor junior scientists and provide scientific guidance across the organization
Drive continuous improvement of toxicology processes, tools, and scientific approaches
Qualifications / Skills
Typically PhD in Toxicology, Pharmacology, or related life sciences field with 10+ years of relevant industry experience or relevant combination of education and experience
Demonstrated expertise in nonclinical safety assessment across multiple therapeutic modalities or indications
Proven ability to lead toxicology strategy for programs advancing into clinical development
Experience supporting regulatory submissions and interacting with health authorities preferred
Strong scientific judgment with the ability to interpret complex and ambiguous data sets
Ability to influence cross-functional teams without direct authority
Effective communication skills, including the ability to translate technical findings into business and clinical implications
Salary Range: $171,000.00 to $223,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
