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 Overview

We are seeking a dynamic, experienced Head of Nonclinical Development to establish and lead the strategy and execution of pre- and nonclinical development across our portfolio of RNA therapeutics. This executive will oversee pharmacology, toxicology, and drug metabolism and pharmacokinetics, integrating these disciplines into a cohesive development strategy while serving as a key member of the R&D leadership team.

The portfolio includes clinical-stage assets in rare central nervous system indications. The ideal candidate combines broad scientific expertise and industry perspective with strong organizational leadership and the ability to communicate effectively with executive leadership, regulatory authorities, and cross functional teams.

This individual will inherit technically strong functional teams spanning vitro pharmacology, in vivo pharmacology, DMPK, and toxicology. A key priority will be developing the current functional leaders, fostering a culture of collaboration, and ensuring operational and strategic integration as we grow the organization to support an expanded pipeline.

Key Responsibilities

Establish vision and provide strategic and organizational enterprise leadership across pharmacology, toxicology, and DMPK, setting the direction for a high performing nonclinical function.
Lead, mentor, and develop functional heads of nonclinical departments, building leadership capabilities, succession depth, and a strong pipeline of scientific talent.
Build a collaborative, productive nonclinical organization with clear accountability, effective decision-making, strong communication across functions, and a culture of scientific rigor, excellence and urgency for patients.
Establish integrated nonclinical development strategies that support candidate selection, clinical entry, progression through late-stage development and regulatory submissions from IND through registration.
Provide strategic oversight of Discovery to Early Development transition, ensuring delivery of relevant translational models, biomarker strategies, and data packages support proof of concept, safety assessment, clinical dose-selection and portfolio advancement and prioritization.
Ensure fit for purpose program strategies, rigorous data analysis and interpretation to support smooth translation of therapeutic programs from preclinical to clinical stage.
Provide scientific and strategic guidance across diverse therapeutic programs, ensuring alignment among nonclinical, clinical, regulatory, CMC, discovery, and program leadership teams with respect to development strategy and plans.
Lead nonclinical content generation and messaging for regulatory submissions such as IND, NDA, and other global regulatory submissions, and representation at interactions with regulatory agency authorities.
Evaluate and proactively manage external partners, including contract research organizations, consultants, and scientific collaborators, to ensure timely execution, adherence to budget and overall operational excellence.