Senior Director, Toxicology

Kailera Therapeutics, Inc. is seeking a Senior Director, Toxicology to lead non-clinical safety strategies across multiple development programs. This role requires deep scientific and regulatory expertise, cross-functional leadership, and operational excellence. The Senior Director will drive departmental strategy, oversee CROs, author regulatory submissions, and present findings to senior leadership. The position is hub-based in Waltham, MA, requiring 3-4 days onsite per week.

Must Have

• Develop and lead non-clinical strategies across development programs
• Serve 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
• Provide technical leadership on strategically critical initiatives, including study design, data interpretation, and risk assessment
• Oversee CROs conducting non-clinical development studies (e.g. chronic tox, carcinogenicity, DART, mechanistic studies)
• Author, review, and approve regulatory submissions (e.g., INDs, NDAs, Investigator’s Brochures, PIPs, briefing books, white papers)
• Represent Kailera and non-clinical development in meetings with regulatory agencies
• Apply in-depth knowledge of own function and broad industry awareness
• Solve highly complex problems and lead others in addressing issues of diverse scope
• Apply broad industry and commercial awareness to drive financial and operational performance
• Review information and data in the context of mid- and long-term project goals
• 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
• Lead and mentor a high-performing non-clinical development team
• Direct the activities of cross-functional, complex, multi-disciplinary projects or teams
• Mentor team members to achieve project goals and support career development
• 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
• 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

Good to Have

• DABT or equivalent strongly preferred

Perks & Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants

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.

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

Salary Range

$210,000 - $270,000 USD

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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