Director Toxicology

ppAre you looking to lead cutting-edge toxicology research that accelerate clinical breakthroughs in biotech? /ppProclinical 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. /ppbr/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. /ph3Key Responsibilities /h3ulliProvide strategic leadership for nonclinical safety activities across a range of therapeutic development projects. /liliDirect the planning, monitoring and scientific evaluation of toxicology and safety studies conducted to regulatory standards. /liliCoordinate external research partnerships, ensuring studies are delivered efficiently, on schedule and within agreed financial parameters. /liliContribute scientific expertise to regulatory documentation and submissions for global development programmes. /liliAnalyse and integrate nonclinical datasets, including safety, pharmacology and ADME/PK findings, to support programme progression. /liliLead the identification, evaluation and mitigation of safety-related risks throughout the product development lifecycle. /liliWork collaboratively with cross-functional teams spanning research, development, manufacturing and regulatory disciplines. /liliProvide scientific input during interactions with regulatory agencies and support responses to regulatory enquiries. /liliCommunicate complex nonclinical findings effectively to project teams, leadership groups and external collaborators. /liliShare knowledge and provide guidance to colleagues, helping to strengthen scientific capability across the organisation. /li /ulh3Requirements /h3ulliPhD, DVM or equivalent in Toxicology, Pharmacology or a related scientific discipline /liliSignificant experience within biotechnology, pharmaceutical or biopharmaceutical drug development /liliProven expertise in GLP toxicology and nonclinical safety assessment /liliExperience supporting IND and/or CTA submissions /liliStrong understanding of ICH guidelines and regulatory expectations /liliExperience managing outsourced toxicology programmes and CRO partners /liliExcellent communication, leadership and stakeholder management skills /liliAbility to influence development strategy within a complex, cross-functional environment /li /ulh3Preferred Experience /h3pExperience within one or more of the following areas would be advantageous: /pulliBiologics /liliOligonucleotide therapeutics /liliGene therapy /liliCell therapy /liliRare diseases /liliAdvanced therapeutic modalities /li /ulh3What's on Offer? /h3ulliOpportunity to influence the development strategy of innovative therapies addressing significant unmet medical needs /liliHighly visible leadership position within a growing clinical-stage biotechnology company /liliExposure across multiple programmes and stages of development /liliCollaborative, entrepreneurial and science-led culture /liliCompetitive salary, annual bonus and equity package /liliOpportunity to work alongside experienced leaders across drug development, regulatory affairs and translational sciences /li /ulpIf you are having difficulty in applying or if you have any questions, please contact bNeil Walton /bat /p /p #J-18808-Ljbffr