Job Description

2025! This is the year that Global Clinical supply is targeting for completing the evolution our systems into a \xe2\x80\x9cdigital enabled\xe2\x80\x9d landscape of 300+ associates. Join a team of globally collaborative colleagues at the \xe2\x80\x98Global Clinical Supply (GCS)\xe2\x80\x99 function to support clinical trials from Phase 1 to approval and be a key interface between Technical Research & Development (TRD) teams and the Clinical teams! At GCS, we aspire to become a data and digital powered, resourceful , agile organization to deliver more products to more patients efficiently, through empowered and highly capable teams.

Your responsibilities include, but are not limited to:

• Represents GCS as a core member in the integrated Clinical Trial Team (iCTT); defines and advises the iCTT on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency and risk management.
• Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule.
• Creates and maintains complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate overage and by using defined processes and systems.
• Creates and drives finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial.
• Defines clinical supply parameters for NIRT set up and initiates subsequent updates throughout the duration of the clinical trial
• Develops and executes a trial-level project plan together with all other relevant roles. Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity
• Collaborates with all relevant line function partners for country submission and approval timelines (including IND-IMPD amendment) to develop optimal supply strategy.
• Generates optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions. Triggers and tracks shipments of IMPs from central depot to regional hubs and local depots.