What You’ll Do:

The Senior Director of Toxicology is a strategic and externally recognized expert responsible for driving the non-clinical safety strategy across multiple development programs. This role combines deep scientific and regulatory expertise with cross-functional leadership, operational excellence, and organizational development. The Senior Director is a functional leader in complex, multidisciplinary teams, developing and executing departmental strategy to ensure alignment with clinical development, corporate goals, regulatory compliance, and organizational vision.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities: 

• Develop and lead non-clinical strategies across development programs, serving as the functional lead for non-clinical on cross-functional Program Teams
• Execute functional business plans and contribute to the development of broader functional strategy to achieve key business objectives
• Make program decisions guided by functional priorities and company strategy that impact the results of core business functions and facilitate cross-functional collaboration
• Provide technical leadership on strategically critical initiatives, including study design, data interpretation, and risk assessment, maintaining external recognition as an expert in the field
• Oversee CROs conducting non-clinical development studies (e.g. chronic tox, carcinogenicity, DART, mechanistic studies), ensuring scientific rigor and regulatory compliance
• Author, review, and approve regulatory submissions (e.g., INDs, NDAs, Investigator’s Brochures, PIPs, briefing books, white papers) and represent Kailera and non-clinical development in meetings with regulatory agencies
• Apply in-depth knowledge of own function and broad industry awareness to differentiate Kailera from the competition
• Solve highly complex problems and lead others in addressing issues of diverse scope, applying ingenuity, sophisticated analytical thought and creative solutions
• Apply broad industry and commercial awareness to drive financial and operational performance ensuring accurate budgeting and resource allocation
• Review information and data in the context of mid- and long-term project goals, directing the course of research and influencing organizational vision
• Use independent judgement to determine methods, techniques, and criteria for obtaining broad results
• Present non-clinical findings and strategic recommendations to senior leadership and external stakeholders
• Influence decision-making across functions by translating complex data into actionable insights
• Take the perspective of others into account when making final decisions related to operational and administrative matters
• Lead and mentor a high-performing non-clinical development team, fostering a culture of scientific excellence, collaboration, and continuous feedback and development
• Lead with trust, understanding, and adaptability to drive followership across the organization
• Direct the activities of cross-functional, complex, multi-disciplinary projects or teams, including prioritization and resource planning
• Mentor team members to achieve project goals and support career development

Required Qualifications: 

• Proven track record of leading non-clinical contributions to complex, multi-disciplinary projects and teams
• Proven track record of successful preparation, submission, and acceptance of non-clinical component of regulatory filings such as INDs, PSPs, NDAs, BLAs
• Deep understanding of GLP, regulatory requirements, and non-clinical development strategies
• Strong communication, leadership, execution and strategic thinking skills

Preferred Qualifications: 

• DABT or equivalent strongly preferred

Education:

• Bachelor’s degree with 12+ years of relevant experience, or an advanced degree (PhD, PharmD, DVM) with 10+ years of experience in toxicology or related field