Senior Director, Toxocology

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 preferred
• At least seven years of industry experience in Toxicology or a relevant field
• Track record successfully supporting therapeutic programs from target identification through development (and ideally registration) with small molecules and/or oligonucleotides
• Experience in all aspects of toxicology including general, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology
• Knowledge of FDA GLP and ICH guidelines
• Experience authoring regulatory documents and interacting with FDA, EU and other global regulatory agencies.
• Effective management of external collaborations and service providers (CROs) and ability to bring pragmatic business-minded approach to balancing internal and external capabilities and workflow
• Familiarity with oligonucleotides or messenger RNA therapeutics is preferred
• Experience with drug development in the CNS and/or eye is preferred
• Strong organizational, collaboration and recordkeeping skills are required
• Strong presentational skills to be able to communicate to both internal and external audiences, including both technical and management audiences
• Highly motivated cross-functional team player with the ability to work in a fast-paced environment.
• Ability to provide novel, innovative solutions to challenging problems.

Location(s)

Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This is a hybrid position.

Travel

This position will require approximately 10% travel.