Clinical Supply Chain, Senior Manager

Our client is a young exciting publicly listed clinical-stage company dedicated to transforming the lives of patients within its therapy areas. With its novel and proprietary drug products and current clinical development programs our client is aiming to provide improved treatments for patients with increased remission rates, faster onset of action, durable effects, and improved tolerability and convenience. This requires experience and a track record of successful development in complex and innovative areas, and excitement for creating something new and ground breaking.

Role is hybrid based, across Ireland, The UK, Italy, Spain or Belgium.

Applicants MUST HAVE 6–9 years in clinical supply chain, of which at least 2–3 in a senior or lead role with direct Phase 3 IMP supply accountability

This experienced Senior Clinical Supply Chain Manager (SCM) will lead end-to-end investigational medicinal product (IMP) and study device supply for early to late-stage global studies. Operating in a fully virtual manufacturer model, they will own the complete clinical supply lifecycle — from demand forecasting and vendor management through to controlled drug compliance, distribution, returns and destruction.

Reporting directly to the Clinical Supply Chain Director, this is a senior, autonomous role requiring the confidence to manage complex vendor relationships and represent the business in governance forums independently. They will own the study-level supply chain Gantt, risk register and budget, and work as a close peer to the Senior CSC Manager leading the upstream CMC and device supply planning.

The role may also include acting as line management for more junior SCM roles.

• Develop and maintain rolling IMP and device demand forecasts linked to clinical enrolment projections and IRT resupply signals.
• Monitor IMP and device inventory at depot and site level; define and maintain minimum stock thresholds; elevate supply risk proactively.
• Run scenario planning for enrolment ramp-up, ramp-down and protocol amendment impacts on supply.
• Review and approve stock replenishment proposals within the clinical supplies vendor's planning cycle.
• Serve as primary relationship owner for the clinical supplies’ vendors across supply planning, quality and logistics work streams as well as IRT vendor management vendors.
• Negotiate, execute and maintain the Master Services Agreement (CSA/MSA) and Quality Agreement.
• Review and maintain study related supply chain budget; issue and track Purchase Orders; manage invoice reconciliation.
• Lead periodic vendor governance meetings, own action logs and escalation tracking.

• Manage all IMP pack and labelling campaigns: agree campaign schedules, approve packaging batch records and review labelled unit reconciliation.
• Co-ordinate master label generation and label management, ensuring compliance with EU CTR, FDA 21 CFR Part 312 and other applicable regulations across all study regions.
• Ensure sharing of all documentation required for QA/QP release including regulatory approvals, Product specification Files, IMPD/IND etc.

• Own the supply chain configuration, resupply logic and dispensing parameters in the IRT system (Suvoda).
• Lead IRT UAT for supply chain modules at study build and amendment.
• Manage ongoing IRT data quality; initiate and approve parameter changes in response to protocol or supply plan changes.

• Oversee clinical site supply: manage depot-to-site shipment scheduling for IMP, devices and ancillaries.
• Co-ordinate cross-border import/export of IMP and devices across all active countries; manage import/export licence requirements and broker relationships.
• Ensure…