Director Toxicology

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 with 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 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