Director Toxicology

Join a Dynamic Clinical-Stage Biotechnology Company

If you are passionate about leading innovative toxicology research that propels clinical advancements in biotech, consider an exciting opportunity with a clinical-stage biotechnology company committed to developing groundbreaking therapies for serious diseases.

Role Overview

As part of a well-funded, science-driven organization, you will provide scientific and strategic leadership, influencing and shaping the nonclinical strategy while collaborating closely with teams in Research, Clinical Development, Regulatory Affairs, and CMC. This role is critical for supporting the advancement of programs from preclinical development through clinical stages.

Key Responsibilities

• Provide strategic leadership for nonclinical safety activities across diverse therapeutic development projects.
• Direct the planning, monitoring, and scientific evaluation of toxicology and safety studies conducted to regulatory standards.
• Coordinate external research collaborations, ensuring studies are completed promptly and within budget.
• Contribute scientific expertise to regulatory documentation and submissions for global development programs.
• Analyze and integrate nonclinical datasets, including safety, pharmacology, and ADME/PK findings, to support program advancements.
• Lead the identification and mitigation of safety-related risks throughout the product development lifecycle.
• Work collaboratively with cross-functional teams spanning research, development, manufacturing, and regulatory disciplines.
• Provide scientific input during interactions with regulatory agencies and assist in responding to regulatory inquiries.
• Effectively communicate complex nonclinical findings to project teams, leadership groups, and external partners.
• Share knowledge and mentor colleagues to enhance scientific capability across the organization.

Requirements

• A PhD, DVM, or equivalent in Toxicology, Pharmacology, or a related scientific discipline.
• Significant experience in biotechnology, pharmaceutical, or biopharmaceutical drug development.
• Proven expertise in GLP toxicology and nonclinical safety assessment.
• Experience supporting IND and/or CTA submissions.
• Strong understanding of ICH guidelines and regulatory expectations.
• Experience managing outsourced toxicology programs and CRO partners.
• Excellent communication, leadership, and stakeholder management skills.
• Ability to influence development strategies within a complex, cross-functional environment.

Preferred Experience

• Experience in any of the following areas: Biologics, Peptides, Oligonucleotide therapeutics, Gene therapy, Cell therapy, Rare diseases, Advanced therapeutic modalities, or Novel drug development platforms.

What’s on Offer?

• The chance to influence the development strategy of innovative therapies addressing significant unmet medical needs.
• A highly visible leadership position within a growing clinical-stage biotechnology company.
• Exposure across multiple programs and stages of development.
• A collaborative, entrepreneurial, and science-led culture.
• Competitive salary, annual bonus, and equity package.
• The opportunity to collaborate with experienced leaders across drug development, regulatory affairs, and translational sciences.