What You’ll Do:

The primary responsibility for the Scientist II, Toxicology will be to function as a key pharmacology and toxicology liaison/subject matter expert in support of external contract research organization (CRO) activities. The Scientist II, Toxicology is expected to ensure non-clinical studies are conducted in accordance with protocols and are aligned with the overall development strategy. In addition, the successful candidate will actively participate in scientific discussions within the non-clinical group for all compounds across the portfolio.

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

Responsibilities:

• Serve as the primary Kailera representative (Study Monitor) for non-clinical (pharmacology and toxicology) studies conducted at CROs
• Collaborate with Non-clinical Project Leaders and other scientists to design and develop study protocols, ensuring CROs have the technical capabilities to meet study requirements
• Conduct site visits to CROs to assess technical capabilities and ensure studies are executed in strict accordance with protocols
• Act as the first line of contact for study-related issues, assessing their impact on study integrity and escalating as needed
• Ensure GLP compliance, adherence to Good Laboratory Practices, and alignment with company Standard Operating Procedures (SOPs)
• Maintain study timelines and ensure non-clinical studies are conducted in accordance with overall program objectives
• Communicate study findings to non-clinical leadership and program teams in a timely and comprehensive manner
• Review and edit study protocols and reports to ensure scientific rigor, regulatory compliance (GLP, animal welfare, and safety), and high-quality study interpretation
• Serve as the point of contact for the receipt, review, and dissemination of study data across the department
• Collaborate with Non-clinical Project Leaders to interpret and analyze pharmacology and toxicology data, supporting risk assessment and decision-making
• Coordinate and oversee internal study data reviews to ensure alignment with project timelines
• Consolidate and communicate internal feedback on study reports to CROs, ensuring clarity and consistency
• Assist Non-clinical Project Leaders in integrating and assembling toxicology data for regulatory submissions (e.g., IND, NDA, BLA)
• Lead and contribute to cross-functional initiatives within the non-clinical department and across other teams to advance Kailera’s research objectives
• Actively participate in scientific discussions to assess toxicology findings and implications for drug development
• Provide mentorship and guidance to junior scientists, fostering a culture of scientific excellence and collaboration
• Take on additional responsibilities as assigned by non-clinical leadership

Required Qualifications:

• Hands-on experience in animal husbandry and in vivo study conduct within a pharmacology or toxicology setting
• Strong understanding of scientific principles and study design in toxicology research
• Knowledge of regulatory policies and procedures related to GLP study design, execution, and reporting
• Familiarity with current trends in non-clinical safety assessment and the CRO landscape
• Excellent written and verbal communication skills, with the ability to author clear, concise, and accurate documents for global regulatory submissions and health authority interactions
• Solid understanding of ICH, FDA, and EMA guidelines related to the nonclinical assessment of drug candidates

Education:

• PhD in Biology, Animal Sciences, Toxicology, or a related field with 2-5 years of relevant experience OR Master’s degree with 8+ years of experience OR Bachelor’s degree with 10+ years of relevant experience

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