Job SummaryThe Senior Director of Toxicology will serve as the strategic and technical lead for nonclinical safety and efficacy evaluation of a growing pipeline of innovative biologic therapies. You'll lead toxicology programs from early discovery through clinical development and global regulatory submissions (IB, IND, CTA, BLA). As a primary subject-matter expert, you will guide cross-functional teams, manage external CROs, and serve as the face of toxicology for global regulatory agencies. Your expertise will be essential for identifying safety issues, collaborating with regulatory experts, and communicating critical results to project teams and company leadership. This position reports into to the Chief Scientific Officer.
Primary Responsibilities- Design and direct comprehensive, scientifically rigorous non-clinical toxicology and safety pharmacology strategies tailored specifically for biologics (e.g., mAbs, bispecifics, fusion proteins, and novel modalities, ensuring alignment with clinical development goals and regulatory requirements.
- Conduct safety evaluations on treatment targets during early stages to proactively detect potential safety concerns.
- Develop mitigation strategies to address safety issues.
- Work closely with regulatory experts to facilitate the smooth transition of biologics into development and First-in-Human (FIH) trials.
- Collaborate with scientific leadership, strategic outsourcing partners, and consultants to design and implement investigative toxicology studies.
- Support research and development efforts through well-designed toxicology studies.
- Ensure the accuracy, validity, and completeness of scientific information in non-GLP and GLP non-clinical research.
- Prepare regulatory documentation related to toxicology studies (e.g., IND, IB, CTA, BLA, submissions).Represent the company as the primary toxicology expert in meetings with health authorities.
- Communicate critical results, interpretations, and project information to various stakeholders, including project teams and company leadership.
- Manage nonclinical Contract Research Organizations (CROs) and vendor management for specific programs.
Required Skills- Proven experience leading the toxicology strategy for successful IND/CTA filings; direct experience with BLA/MAA submissions is strongly preferred.
- DABT certification or veterinary degree with pathology training.
- Deep understanding of the unique challenges of biologics toxicology, including immunogenicity, tissue cross-reactivity (TCR), species selection, and PK/PD relationships.
- Expert knowledge of ICH, FDA, and EMA guidelines governing the non-clinical safety testing of biological products, alongside strict adherence to GLP standards.
Preferred Skills- Expertise in either Biologics-related toxicology or developmental and reproductive (DART)-related toxicology
- Demonstrated ability to collaborate effectively in a team environment
Education Requirements- PhD or DVM in Toxicology, Pharmacology, Pathology with 10+ years of toxicology experience in the pharmaceutical industry, or Master's in Toxicology with 15+ years of experience with a documented track record of successfully advancing biologics from discovery through late-stage clinical development
This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.
Potential base pay range
$258,000-$303,000 USD
