Clinical Supply Chain, Senior Manager
From $21/yr
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 Job Spec 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. Demand Forecasting \& Inventory Management * 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; escalate 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. Vendor Management * Serve as primary relationship owner for the clinical supplies’ vendors across supply planning, quality and logistics workstreams 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. Pack \& Labelling Operations * 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. IRT Platform Management * 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. Distribution \& Depot Oversight * 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 controlled drug licences, including DEA quota requirements, are in place at depot level across all active jurisdictions; monitor renewal timelines to prevent supply interruptions. Returns \& Destruction * Manage returns logistics from clinical sites; oversee IMP and device reconciliation against IRT dispensing records. * Co-ordinate GMP/GDP and DEA-compliant destruction across all active markets; obtain, review and archive destruction certificates. Controlled Drug Compliance (US, EU \& UK) * Maintain oversight of controlled drug licence requirements and status across all vendors in US (DEA Schedule I), EU (national authorities) and UK (Home Office). * Track import/export licence requirements for all IMP shipment lanes; maintain the controlled drug shipment tracker. * Support regulatory inspection readiness for controlled drug supply chain documentation. Quality, GMP \& TMF * Maintain the clinical supplies vendor's approved supplier status; support QA-led audits. * Support deviations, CAPAs and change controls; ensure GMP/GDP compliance across all supply chain activities. * Ensure all clinical supply chain documents are filed to the Trial Master File in accordance with ICH E6(R3) and EU CTR; co-ordinate vendor document delivery. Study Governance \& Budget * Own and maintain the study-level supply chain Gantt chart and risk register; escalate and mitigate risks proactively. * Own and manage the study supply chain budget; track PO spend vs. budget; report variances monthly to the CSC Director. * Build and maintain the study RACI; support integrated demand planning linking IRT signals to manufacturing and distribution schedules. Clinical Operations/ Pharmacy Management Interface * Partner with Clinical Operations and pharmacy management team to support site activation supply readiness. * Respond to site-level supply escalations (stock queries, shipment delays, excursions) as required. Person Specification Competency Requirement Phase 1-3 clinical supply chain Demonstrated end-to-end ownership of IMP and/or device supply chains in a Phase 1-3 clinical context, including depot management, distribution and site supply across multiple geographies IRT platform management Hands-on experience with clinical IRT systems (Suvoda preferred; equivalents considered); direct experience managing UAT, lot release testing and resupply configuration Pack \& labelling management Practical experience managing IMP packaging campaigns and label management across EU CTR and FDA 21 CFR Part 312 frameworks; label version control and change management Controlled substance supply chain Working knowledge of Schedule I (or equivalent) CD licence requirements across US (DEA), EU national authorities and UK Home Office; import/export licence management and depot licence oversight Distribution \& logistics Track record managing multi-country IMP and device distribution and returns management including depot oversight, cross-border import/export and courier management TMF \& document management Familiarity with TMF structure and supply chain document filing obligations under ICH E6(R3) and EU CTR Virtual manufacturer model Experience managing clinical supply chains in a virtual pharmaceutical company with outsourced manufacturing, packaging and distribution Stakeholder management Credible, independent operator capable of managing senior vendor relationships and representing in governance forums Years of experience 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 Education Degree in life sciences, pharmacy, supply chain or a related discipline; postgraduate qualification advantageous Gerry Kennedy, Managing Director, Recruitment for Technology Ltd. gerry@rftgroup.ie 00 353 87 2834400