Biotech Project Manager – Oncology (CMC/Clinical Support)

Role:
Biotech Project Manager – Oncology (CMC / Clinical Support)Location:
Galway, Ireland (on-site)The CompanyThis pioneering cell therapy biotech is developing a breakthrough neutrophil-based platform designed to transform the treatment of solid tumours. Unlike patient-specific T-cell therapies, their approach is donor-derived, scalable, and consistent, enabling true manufacturing at scale and efficient delivery to patients. The therapy harnesses the natural tumour-fighting abilities of neutrophils, which can also be engineered to enhance anti-cancer activity.The company is entering an exciting growth phase, with its first-in-human clinical trial due to begin in Galway within the next 12 months. GMP manufacturing is supported by a specialist CDMO partner, while the UK headquarters lead innovation, translational research, and CMC strategy. With strong leadership and a clear clinical path ahead, this is a rare opportunity to be part of a next-generation oncology therapy at the point where science translates into patient impact.The TeamThe role reports directly to the CSO, working closely with senior scientific and operational leaders.The OpportunityThis is a newly created role supporting the upcoming tech transfer and clinical trial readiness in Galway. As Project Manager, you will be central to stakeholder coordination, compliance, and operational delivery, ensuring timelines and governance for this high-impact oncology programme are met.Key Responsibilities• Manage timelines and milestones for trial readiness in Galway• Liaise with CDMO partner and CSO on project progress• Support compliance, documentation, and governance requirements• Drive cross-functional coordination across CSO, CDMO, and internal teams• Provide regular progress reporting to leadership (CSO and Chief Development and Regulatory Officer)Requirements• Proven project management experience in a regulated life sciences environment, ideally with CMC exposure• Strong organisational, communication, and stakeholder management skills• Experience leading cross-functional projects with CDMOs, CSOs, and regulatory stakeholders• Based in, or willing to relocate to, Galway and able to work primarily on-site
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