Senior Director, Toxocology

Role: Senior Toxicologist responsible for leading nonclinical safety assessments to support Stoke Therapeutics' gene-based drug programs, including antisense oligonucleotides for CNS and eye diseases. Responsibilities: oversee design, management, and interpretation of in vitro/in vivo toxicology studies; coordinate with CROs; prepare regulatory safety data for INDs, CTAs, NDAs; develop safety strategies aligned with industry guidelines; and interact with regulatory agencies. Requirements: Ph.D. in Pharmacology, Toxicology, or DVM; 7+ years in industry supporting therapeutic development, with experience in toxicology across general, reproductive, carcinogenicity, and safety pharmacology; FDA GLP and global regulatory experience; strong CRO management skills. Preferred: DABT certification, experience with oligonucleotides or mRNA therapeutics, drug development in CNS or ocular indications. HighValue: biopharma, gene therapies, RNA modalities, CNS and eye indications, safety pharmacology, regulatory document authoring, global agency interactions. WorkSetup: hybrid Bedford/Waltham MA; travel ~10%.