Overview
In this role you will define the IMP design and supply strategy to ensure adequate clinical trial supply, lead a cross-functional team, and manage timelines and risks to avoid stockouts. You will liaise with Regulatory and CMC groups to align on strategy, and represent GCSM in study-wide discussions. The position sits within Global Clinical Supply Management and contributes to Ipsen’s mission of improving patient outcomes. This is a hands-on role with significant cross-functional collaboration and impact on trial success.
Responsibilities
- Facilitate a cross-functional CSC sub team handling study setup, QA, packaging, distribution, and CDMO management
- Represent GCSM in clinical study team meetings ensuring alignment with milestones
- Define project objectives with the sub team and develop comprehensive project plans to ensure on-time supply
- Validate strategy with the Clinical Supply Chain Therapeutic Area Lead
- Collaborate with Global Regulatory Affairs and CMC to align regulatory strategy
- Assess impact of changes to scope, schedule, and costs; mitigate with timely plans
- Escalate issues to management when needed and maintain risk assessment to minimize risks
- Track performance with PM tools and report progress to stakeholders
- Support representation of GCSM in CMC project meetings and Clinical Operations strategic meetings
- Design IMP kits with packaging partners or CDMO; manage labeling and documentation
- Forecast material needs with study forecasters and regularly update forecasts
- Organize resupply meetings and monitor validated study forecasts; adjust for country/site changes
- Ensure compliance with internal/external guidance and harmonized processes; manage deviations and change controls
- Lead continuous improvement within GCSM and participate in lessons learned
- Maintain QEEHS and CSR responsibilities as per Ipsen guidelines
Key requirements
- Approximately 3–5 years’ experience in pharmaceutical industry with international exposure
- Experience managing complex investigational supplies for global clinical trials
- Experience in project management and cross-functional communications in a matrixed environment
- Bachelor’s degree or global equivalent in relevant fields
- English required; French preferred
- Experience with RTSM platforms and external CDMOs (preferred)
- Advanced Excel and forecasting tools (preferred)
- Knowledge of GMP, regulatory submissions, and CMC processes (essential)
- Excellence in execution
- Accountability
- Effective communication
- RTSM platforms (preferred)
- Advanced Excel and forecasting tools
- Risk assessment and mitigation
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