Director Toxicology

Proclinical Group; Leiden; On-site; EUR 180,000 - 240,000; Full time

Job summary

Proclinical is partnering with a clinical-stage biotechnology company developing innovative therapies for serious diseases. We are seeking a Director, Toxicology & Nonclinical Safety to provide scientific and strategic leadership across the development portfolio.

You will collaborate with Research, Clinical Development, Regulatory Affairs and CMC teams to shape nonclinical strategy from preclinical through clinical development, oversee external CROs, and support global regulatory activities.

Qualifications

• PhD, DVM or equivalent in Toxicology, Pharmacology or related field.
• Significant experience in biotech/pharma 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 programmes and CRO partners.
• Excellent communication, leadership and stakeholder management skills.
• Ability to influence development strategy within a complex, cross-functional environment.

Responsibilities

• Provide strategic leadership for nonclinical safety across therapeutic projects.
• Plan, monitor and evaluate toxicology and safety studies to regulatory standards.
• Coordinate external research partnerships with timely, on-budget delivery.
• Contribute scientific input to regulatory documentation for global programs.
• Analyse nonclinical data (safety, pharmacology, ADME/PK) to support progression.
• Identify and mitigate safety-related risks across product development.
• Collaborate with research, development, manufacturing and regulatory teams.
• Provide input during interactions with regulatory agencies and respond to inquiries.
• Communicate complex nonclinical findings to teams and leadership.

Skills

Leadership

Regulatory communication

Stakeholder management

Cross-functional collaboration

Education

PhD, DVM or equivalent in Toxicology/Pharmacology

Job description

Are you looking to lead cutting-edge toxicology research that accelerate clinical breakthroughs in biotech?

Proclinical is working with a clinical-stage biotechnology company developing innovative therapies for serious diseases is seeking a Director, Toxicology & Nonclinical Safety to provide scientific and strategic leadership across its growing development portfolio.

This is an exciting opportunity to join a well-funded, science-driven organisation at a pivotal stage of growth. Working closely with Research, Clinical Development, Regulatory Affairs and CMC teams, you will play a key role in shaping nonclinical strategy and supporting the progression of programmes from preclinical development through clinical development. The successful candidate will serve as the organisation's subject matter expert for toxicology and nonclinical safety, providing strategic guidance across multiple programmes while overseeing external partners and supporting global regulatory activities.

Key Responsibilities

• Provide strategic leadership for nonclinical safety activities across a range of 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 programmes.
• Analyse and integrate nonclinical datasets, including safety, pharmacology and ADME/PK findings, to support programme 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 enquiries.
• Communicate complex nonclinical findings effectively to project teams, leadership groups and external collaborators.
• Share knowledge and provide guidance to colleagues, helping to strengthen scientific capability across the organisation.

Requirements

• PhD, DVM or equivalent in Toxicology, Pharmacology or a related scientific discipline
• Significant experience within 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 programmes and CRO partners
• Excellent communication, leadership and stakeholder management skills
• Ability to influence development strategy within a complex, cross-functional environment

Preferred Experience

Experience within 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 programmes 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