Vice President, 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.

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.