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Kailera Therapeutics · 4 days ago

Senior Director, Toxicology

Waltham, Massachusetts

Full-time

Hybrid

Director/Executive

$210K/yr - $270K/yr

10+ years exp

Kailera is committed to developing therapies that transform lives and improve health. The Senior Director of Toxicology will lead the non-clinical safety strategy across multiple development programs, combining scientific expertise with cross-functional leadership to ensure alignment with clinical development and regulatory compliance.

BiotechnologyPharmaceuticalTherapeutics

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

Qualification

Non-clinical developmentRegulatory submissionsGLP knowledgeLeadership skillsStrategic thinkingOperational excellenceCommunication skillsTeam mentoringCross-functional collaborationProblem-solving

Required

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