Head of Nonclinical Development - Non Clinical Development

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.
• Communicate nonclinical strategy, program risks, and development recommendations clearly to executive leadership and other key stakeholders, including presentations to the executive leadership team and Board of Directors.
• Serve as a key pillar of the R&D leadership team, helping define and execute the company’s drug development vision and strategy while driving a collaborative, egalitarian culture driven by scientific rigor, excellence, accountability, portfolio focus, and patient impact and defined by kindness and mutual respect.

Candidate Qualifications

• Advanced degree in pharmacology, toxicology, pharmaceutical sciences, or a related discipline; PhD or MD required.
• Significant leadership experience within biotechnology or pharmaceutical drug development, preferably including rare diseases.
• Demonstrated expertise across the development continuum leading pharmacology, toxicology, and DMPK, with the ability to integrate these functions into a unified nonclinical strategy.
• Experience developing advanced therapies (e.g., cell and gene, siRNA, mRNA) required.
• Experience advancing programs from discovery through IND and through clinical development, with experience supporting NDA/BLA or equivalent registrational regulatory submission required.
• Strong understanding of regulatory process and stage-appropriate expectations for nonclinical development and the ability to effectively represent nonclinical perspective in interactions with global health authorities.
• Demonstrated success managing and developing technically strong scientific leaders and diverse multidisciplinary teams, building a pipeline of functional talent, while fostering a culture of scientific rigor, excellence, collaboration, and accountability.
• Demonstrated success working across the spectrum of functional partners, including discovery, clinical development, regulatory affairs, CMC, program management, commercial and medical affairs.
• Strong executive presence with the ability to communicate complex scientific issues and recommendations to senior leadership and present effectively to the executive leadership team and Board of Directors.
• Broad, enterprise-oriented perspective with a collaborative approach to decision making and demonstrated experience helping set and execute strategy as part of an R&D leadership team.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $349,000 - $399,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).