Director / Senior Director of Toxicology

Proclinical; Leiden; Hybrid; EUR 95,000 - 135,000; Full time

Job summary

Proclinical is partnering with a clinical-stage biotechnology company to identify a Director/Senior Director of Toxicology & Nonclinical Safety in Leiden, NL. The role leads nonclinical safety strategy, oversees GLP toxicology programs and supports regulatory submissions.

Based in Leiden with four on-site days per week, the senior leader will manage CRO partnerships, guide regulatory interactions and drive safety considerations across multiple programmes in collaboration with R&D and Regulatory

Qualifications

• PhD, DVM or equivalent in Toxicology, Pharmacology or a related scientific discipline.

Responsibilities

• Provide strategic leadership for nonclinical safety activities across multiple development projects.

Skills

Strategic leadership

Nonclinical safety

GLP toxicology

IND/CTA submissions

Cross-functional collaboration

Regulatory affairs

Communication

Stakeholder management

Education

PhD/MD/Veterinary degree in Toxicology or related field

Job description

Director / Senior Director of Toxicology

€95,000 - €135,000 + Bonus + Stock Options

Based in Leiden, NL (4 days on site a week)

Are you looking to define and execute toxicology strategies that enable the progression of innovative RNA therapeutics from discovery through clinical development?

Proclinical is working with a clinical-stage biotechnology company developing innovative therapies for serious diseases is seeking a Director or Senior Deirector of 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

If you are having difficulty in applying or if you have any questions, please contact Neil Walton at [e-mail].