Vice President, Non Clinical Development

Stoke Therapeutics•Bedford, MA

21d•$349,000 - $399,000

About The Position

Stoke Therapeutics is seeking an experienced Head of Nonclinical Development to establish and lead the strategy and execution of preclinical and nonclinical development across its RNA therapeutics portfolio. The role oversees pharmacology, toxicology, and drug metabolism and pharmacokinetics (DMPK), integrating these disciplines into a cohesive development strategy and serving as a key member of the R&D leadership team. The portfolio includes clinical-stage assets for rare central nervous system indications. The executive will lead technically strong functional teams spanning in vitro and in vivo pharmacology, DMPK, and toxicology. Priorities include developing functional leaders, fostering collaboration, and ensuring operational and strategic integration as the organization expands its pipeline. The position provides enterprise leadership for nonclinical development from discovery through clinical development and regulatory submissions. It requires close coordination with discovery, clinical, regulatory, CMC, program leadership, and other partners, as well as communication of strategy and recommendations to executive leadership, the Board of Directors, and regulatory authorities. Stoke is headquartered in Bedford, Massachusetts. The company describes its work arrangements as flexible, balancing individual needs and preferences with business needs and a desire to foster collaboration and innovation; it values periodically being together in person.

Requirements

PhD or MD in pharmacology, toxicology, pharmaceutical sciences, or a related discipline.
Significant leadership experience in biotechnology or pharmaceutical drug development; rare-disease experience is preferred.
Expertise across pharmacology, toxicology, and DMPK, including the ability to integrate these disciplines into a unified nonclinical strategy.
Experience developing advanced therapies, such as cell and gene therapies, siRNA, or mRNA.
Experience advancing programs from discovery through IND and clinical development, including support for an NDA, BLA, or equivalent registrational submission.
Strong understanding of regulatory processes and stage-appropriate expectations for nonclinical development, and ability to represent the nonclinical perspective in interactions with global health authorities.
Success managing and developing scientific leaders and multidisciplinary teams, developing functional talent, and fostering scientific rigor, excellence, collaboration, and accountability.
Experience working with partners across discovery, clinical development, regulatory affairs, CMC, program management, commercial, and medical affairs.
Executive presence and ability to communicate complex scientific issues and recommendations to senior leaders and present to executive leadership and the Board of Directors.
Broad, enterprise-oriented perspective, collaborative decision-making approach, and experience helping set and execute strategy as part of an R&D leadership team.

Nice To Haves

Experience in rare diseases.

Responsibilities

Establish the vision, strategy, and organizational leadership for pharmacology, toxicology, and DMPK.
Lead, mentor, and develop functional heads, strengthen leadership capabilities and succession depth, and develop scientific talent.
Build a collaborative nonclinical organization with clear accountability, effective decision-making, strong communication, and a culture of scientific rigor, excellence, and urgency for patients.
Establish integrated nonclinical development strategies supporting candidate selection, clinical entry, late-stage development, and regulatory submissions from IND through registration.
Oversee the Discovery to Early Development transition, including translational models, biomarker strategies, and data packages supporting proof of concept, safety assessment, clinical dose selection, and portfolio decisions.
Ensure fit-for-purpose program strategies and rigorous analysis and interpretation of data to support translation from preclinical to clinical development.
Provide scientific and strategic guidance across therapeutic programs and align nonclinical plans with clinical, regulatory, CMC, discovery, and program leadership teams.
Lead nonclinical content generation and messaging for IND, NDA, and other global regulatory submissions, and represent the nonclinical function in interactions with regulatory authorities.
Evaluate and manage external partners, including contract research organizations, consultants, and scientific collaborators, to support timely execution, budget adherence, and operational excellence.
Communicate nonclinical strategy, program risks, and development recommendations to executive leadership and other stakeholders, including the executive leadership team and Board of Directors.
Contribute to the R&D leadership team in defining and executing the company’s drug development vision and strategy, while promoting scientific rigor, excellence, accountability, portfolio focus, patient impact, kindness, and mutual respect.