Biotech Project Manager – Oncology (CMC/Clinical Support)
Location:
Galway, Ireland (on-site)
About the Company
We'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 its
first-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 Opportunity
This newly created role will support the upcoming
tech 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 gain
hands-on experience in clinical trial preparation
at 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 Responsibilities
* Manage timelines for trial readiness in Galway
* Liaise with CDMO partner and CSO
* Support compliance and documentation requirements
* Drive cross-functional coordination across CDMO, CSO, and internal teams
* Provide progress reporting to leadership (CSO and Chief Development & Regulatory Officer)
Requirements
* Proven project management experience in a regulated life sciences setting, ideally with CMC exposure
* Strong organisational 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
* Motivated by start-up/scale-up culture, with resilience, autonomy, and high drive