Head of Preclinical Toxicology

We are seeking a hands‑on strategic and operational Head 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—especially with biologics—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. Key Responsibilities 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, 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. 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. Qualifications and Experience Ph.D. in Toxicology, Pharmacology, or related field with significant experience in preclinical drug development, ideally in oncology or other therapeutic areas. 8–15 years of experience in preclinical toxicology, with at least 5+ years in a leadership or executive role in a biotech or pharmaceutical environment. Extensive experience overseeing preclinical toxicology studies for biologics. Strong experience managing external CROs, contract laboratories, and vendors in the context of preclinical toxicology studies. Proven track record of success in IND filing and preclinical safety data packages for regulatory submissions. Skills Expertise in designing and interpreting toxicology studies, understanding of safety pharmacology, genotoxicity, carcinogenicity, and other core areas of preclinical toxicology. Solid understanding of drug development and the regulatory landscape for biologic therapeutics. In‑depth knowledge of GLP (Good Laboratory Practice) standards and regulatory guidelines. Experience in preparing and presenting data for regulatory authorities and internal stakeholders. Strong leadership and management skills with a proven ability to lead cross‑functional teams. Excellent communication and interpersonal skills, with the ability to effectively communicate complex scientific data to both technical and non‑technical stakeholders. Preferred Qualifications Experience in advancing oncology therapeutics from preclinical through clinical development. Prior experience in a Director / Senior Director / Executive Director role within a biotech company. Familiarity with the latest trends and technologies in preclinical safety and toxicology. What We Offer A high‑impact role in a fast‑paced, mission‑driven biotech company. An opportunity to work alongside world‑class colleagues passionate about scientific innovation and patient outcomes. Competitive compensation and benefits, and a culture committed to continuous learning and career development. The ability to directly shape the trajectory of transformative medicines that matter. Join Us If you’re excited to play a leading role in advancing translational strategies for best‑in‑class therapies, we encourage you to apply. Come be part of a team that’s not just building companies—but changing lives. #J-18808-Ljbffr