Job Description

Stoke Therapeutics seeks an experienced Senior Director of Toxicology to lead nonclinical safety studies for antisense oligonucleotide drug programs. The role involves designing and overseeing preclinical toxicology work, preparing regulatory safety packages, and managing external research partnerships to advance genetic disease treatments through clinical development and registration.

Responsibilities

• Provide technical oversight and leadership for all nonclinical safety studies supporting drug discovery and development programs
• Design and direct management of safety pharmacology, toxicology, and toxicokinetic studies
• Prepare and present nonclinical safety data for project teams, regulators, and executive leadership
• Author toxicology sections in regulatory submissions and coordinate responses to regulatory agencies
• Develop and manage CRO network; identify and oversee external partners conducting appropriate safety studies

Requirements

• Extensive experience designing, executing, and interpreting in vitro and in vivo toxicology studies
• Demonstrated expertise with safety pharmacology and toxicokinetic data analysis and reporting
• Proven track record preparing and reviewing regulatory documents including INDs, CTAs, and NDAs
• Experience managing contract research organizations and coordinating external study execution
• Knowledge of regulatory agency interactions and global development processes
• Strong cross-functional collaboration skills with discovery, chemistry, and clinical teams

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