Associate Director, Toxicology

Role Summary

The Associate Director will be responsible for preparation of preclinical safety data packages for clinical development. 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 individual 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 with global regulatory agencies. This position will report to the Executive Director, Head of Toxicology.

Responsibilities

• Provide leadership, technical oversight, and guidance for all nonclinical safety studies conducted to support discovery and development programs and ensure delivery of a high-quality safety package for development.
• Design and manage nonclinical safety studies, including the evaluation, interpretation an integration of safety pharmacology, toxicology and toxicokinetic information.
• Manage the preparation and presentation of nonclinical safety data for project teams, regulatory agencies, and management.
• Prepare toxicology sections in regulatory documents (IND, CTA, IB and annual reports) and aid in preparation of responses to regulatory agencies.
• Develop an optimal CRO network to support non-clinical safety studies and manage external CROs to conduct appropriate studies.
• Manage toxicology goals, priorities, resource requirements, budget, and timelines.
• Collaborate with Discovery Research, DMPK, Chemistry/CMC functions as well as with key Clinical and Regulatory stakeholders.
• Regularly assess the oligonucleotide drug development field and use best practice for safety studies.
• Represent Stoke Therapeutics toxicology with key external stakeholders, partners, and consultants.

Qualifications

• M.S. similar in Pharmacology, Toxicology, or a relevant discipline and 12+ years of experience or PhD and 8+ years of experience in Toxicology or a relevant field
• Track record supporting drug discovery programs from target identification through development 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 and ideally, EU 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.
• Familiarity with oligonucleotides or messenger RNA therapeutics
• Experience with drug development in the CNS and/or eye is a plus
• Strong organizational and recordkeeping skills.
• Strong presentational skills to be able to communicate to both internal and external 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.

Skills

Education

Additional Requirements

• Location: Bedford, MA (hybrid)
• Travel: approximately 10% travel