Senior Director, Toxicology

About Stoke: Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/ Position Purpose: Stoke is seeking a highly motivated and experienced senior Toxicologist to join a company pioneering genetic disease treatments. The successful candidate will play a key role at Stoke Therapeutics leading the nonclinical toxicology work in support of our drug discovery and clinical programs and will have hands-on responsibility for preparation of preclinical safety data packages for clinical development and product registration. The ideal candidate will have extensive experience with the design, execution and interpretation of in vitro and in vivo toxicology studies. The candidate will be responsible for coordinating and interfacing with CROs to undertake these studies, and will be accountable for the review, analysis and reporting of the safety pharmacology and toxicology data. This leader will need to work across a multi-disciplinary team to advance programs through the pipeline. The successful candidate will have extensive experience of reviewing and creating regulatory documents (INDs, CTAs, NDAs etc.) and interacting successfully with global regulatory agencies. This position currently reports to the Chief Scientific Officer. Key Responsibilities: • Provide leadership, technical oversight, and guidance for all nonclinical safety studies conducted to support Stoke Therapeutics discovery and development programs to ensure delivery of a high-quality safety package for development and registration. • Lead the design and direct management for nonclinical safety studies, including the evaluation and interpretation of safety pharmacology, toxicology and toxicokinetic information. • Manage the preparation and presentation of nonclinical safety data for project teams, regulatory agencies, and executive management. • Prepare toxicology sections in regulatory documents (IND, CTA, NDA, IB and annual reports) and aid in preparation of responses to regulatory agencies. • Develop an optimal CRO network to support nonclinical safety studies and identify, manage external CROs to conduct appropriate studies. • Manage toxicology goals, priorities, resource requirements, budget, and timelines in coordination with program teams. • Collaborate effectively with Discovery Research, DMPK, Chemistry/CMC functions as well as with key Clinical and Regulatory stakeholders. • Regularly assess the evolving oligonucleotide drug development field to ensure awareness and implementation of industry- and regulatory agency-aligned best practice for safety studies. • Represent Stoke Therapeutics toxicology function with key external stakeholders, partners and global regulatory agencies. Required Skills & Experience: • Ph.D. in Pharmacology, Toxicology, or a relevant discipline or DVM is required • A Diplomate, American Board of Toxicology (DABT) or equivalent is preferr