Scientist II, Toxicology

Responsibilities

• Required location: Waltham, MA (hub-based, onsite 3-4 days per week)
• 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
• Salary Range
• $127,000 - $155,000 USD
• EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:
• Kailera Therapeutics, Inc.

Benefits

Additional Information

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

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