Biotech Project Manager – Oncology

17 hours ago


Galway, Ireland Biotalent Full time

Biotech Project Manager – Oncology (CMC/Clinical Support)Location:Galway, Ireland (on-site)About the CompanyWe're working with a pioneering cell therapy biotech developing the world's first neutrophil-based allogeneic platform to treat solid tumours.Unlike patient-specific T-cell therapies, this approach is donor-derived, scalable, and consistent, enabling it to be manufactured at scale and delivered to patients more efficiently.The therapy harnesses the natural tumour-infiltrating and tumour-killing abilities of neutrophils, which can also be engineered to enhance their anti-cancer activity.This makes the platform a differentiated and powerful strategy designed to overcome tumour resistance and improve outcomes.The company is now entering an exciting growth phase, with itsfirst-in-human clinical trial scheduled to begin in Galway within the next 12 months.GMP manufacturing is handled through a specialist CDMO partner, while the wider team drives innovation, translational research, and CMC strategy.Joining now means stepping in at the point where cutting-edge science is moving directly into patients.The OpportunityThis newly created role will support the upcomingtech transfer and clinical trial readiness in Galway.Reporting directly to the CSO, you'll be responsible for coordinating stakeholders, ensuring regulatory and operational compliance, and keeping timelines on track for this high-impact oncology programme.This is an opportunity to gainhands-on experience in clinical trial preparationat a biotech where contributions are visible and ownership is high.Unlike larger pharma environments, here you'll play a pivotal role in shaping a first-of-its-kind therapy as it moves into the clinic.Key ResponsibilitiesManage timelines for trial readiness in GalwayLiaise with CDMO partner and CSOSupport compliance and documentation requirementsDrive cross-functional coordination across CDMO, CSO, and internal teamsProvide progress reporting to leadership (CSO and Chief Development & Regulatory Officer)RequirementsProven project management experience in a regulated life sciences setting, ideally with CMC exposureStrong organisational and stakeholder management skillsExperience leading cross-functional projects with CDMOs, CSOs, and regulatory stakeholdersBased in or willing to relocate to Galway, and able to work primarily on-siteMotivated by start-up/scale-up culture, with resilience, autonomy, and high drive


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