Preclinical Toxicology - AD​/Director

Position: Associate Director / Director, Preclinical Toxicology

Location: Remote or Boston Metro - Hybrid

We are seeking an experienced and highly motivated Associate Director / Director of Preclinical Toxicology to lead and oversee all preclinical toxicology activities for our drug development programs. The ideal candidate will have deep expertise in preclinical toxicology, a solid understanding of drug development, and experience advancing novel therapeutics from discovery through preclinical stages. This individual will be responsible for designing and executing preclinical safety strategies, overseeing toxicology studies, and collaborating with internal teams and external CROs to ensure safe and effective development of new therapeutics.

The successful candidate will have a proven track record in preclinical toxicology and a deep understanding of the regulatory and scientific principles underpinning drug development.

• Develop and implement the preclinical toxicology strategy for early-stage drug candidates, ensuring alignment with the overall drug development pipeline and regulatory requirements.
• Oversee the design, execution, and interpretation of preclinical toxicology studies (GLP and non-GLP), including safety pharmacology, single-dose and repeat-dose toxicity, genotoxicity, carcinogenicity, and reproductive toxicity studies.
• Ensure toxicology studies support IND filings, regulatory submissions, and clinical trial design.

• Work closely with cross-functional teams to assess preclinical safety data and inform decision-making on candidate selection and progression.
• Lead the strategic planning and execution of preclinical safety programs in collaboration with internal teams and external Contract Research Organizations (CROs).
• Partner with regulatory affairs to prepare safety data for regulatory submissions, including IND filings and responses to regulatory inquiries.

• Manage and oversee external CROs and toxicology contract research organizations to ensure timely execution of studies, adherence to GLP standards, and regulatory compliance.
• Ensure the identification and management of key CRO relationships to advance preclinical toxicology programs efficiently.
• Review and approve toxicology study protocols, reports, and deliverables from external partners to ensure scientific rigor and quality.

• Provide strategic leadership to the clinical development team on the safe translation of preclinical toxicology data into clinical trial designs and contribute to the development of clinical risk assessments.
• Collaborate with regulatory authorities and contribute to IND filings, clinical study reports, and other documentation required for regulatory approval.
• Support the creation and submission of non-clinical safety packages for regulatory bodies, ensuring compliance with global guidelines (FDA, EMA, ICH, etc.).

• Stay at the forefront of scientific advancements in preclinical toxicology, particularly in the context of oncology therapeutics, and implement innovative strategies to improve the efficiency and accuracy of toxicology assessments.
• Provide mentorship and leadership to toxicology scientists, promoting scientific excellence, collaboration, and continuous learning within the organization.

• Review and interpret toxicology study data and prepare high-quality reports for internal teams, management, and regulatory submissions.
• Ensure data is communicated effectively to inform development decisions and support company goals.

• Develop and manage the budget for preclinical toxicology activities, ensuring that resources are used efficiently and projects are completed within budget and timeline constraints.
• Optimize resource allocation and ensure that toxicology studies are conducted on schedule and within financial parameters.

• Ph.D. in Toxicology, Pharmacology, or related field with significant experience in…