Director of Toxicology / Directress of Toxicology

Director, Toxicology & Nonclinical Safety

Are you ready to lead groundbreaking toxicology research that accelerates clinical breakthroughs in biotechnology? Proclinical is collaborating with a clinical-stage biotechnology company that is dedicated to developing innovative therapies for serious diseases. We are currently seeking a Director of Toxicology & Nonclinical Safety to provide scientific and strategic leadership across our expanding development portfolio. This is an exciting opportunity to join a well-funded, science-driven organization at a pivotal stage of growth.

In this role, you will work closely with our Research, Clinical Development, Regulatory Affairs, and CMC teams, playing a key role in shaping nonclinical strategy and supporting the progression of programs from preclinical to clinical development. As the organization's subject matter expert in toxicology and nonclinical safety, you will provide strategic guidance across multiple programs while overseeing external partners and supporting global regulatory activities.

Key Responsibilities

• Provide strategic leadership for nonclinical safety activities across various therapeutic development projects.
• Direct the planning, monitoring, and scientific evaluation of toxicology and safety studies conducted to regulatory standards.
• Coordinate external research partnerships, ensuring studies are delivered efficiently, on schedule, and within agreed financial parameters.
• 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 progression.
• Lead the identification, evaluation, 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 support responses to regulatory inquiries.
• Effectively communicate complex nonclinical findings to project teams, leadership groups, and external collaborators.
• Share knowledge and provide guidance to colleagues, helping to strengthen scientific capability across the organization.

Requirements

• 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 strategy within a complex, cross-functional environment.

Preferred Experience

• Experience in one or more of the following areas would be advantageous:
  • Biologics
  • Peptides
  • Oligonucleotide therapeutics
  • Gene therapy
  • Cell therapy
  • Rare diseases
  • Advanced therapeutic modalities
  • Novel drug development platforms

What's on Offer?

• Opportunity to influence the development strategy of innovative therapies addressing significant unmet medical needs.
• Highly visible leadership position within a growing clinical-stage biotechnology company.
• Exposure across multiple programs and stages of development.
• Collaborative, entrepreneurial, and science-led culture.
• Competitive salary, annual bonus, and equity package.
• Opportunity to work alongside experienced leaders across drug development, regulatory affairs, and translational sciences.

If you are interested in this exciting opportunity, please apply online using the form below. Only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter focused on finding exceptional talent and matching them with premier positions worldwide. Proclinical is acting as an Employment Agency in relation to this vacancy.

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