argenx is a clinical & commercial stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique SIMPLE Antibody™ platform and suite of Fc engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.
To further strengthen the Clinical Trial Supply (CTS) team we are looking for a talented Clinical Trial Supply Manager (CTSM). The CTSM represents product supply in the Clinical Study Teams and drives the development and execution of effective product supply strategies in close collaboration with various key stakeholders. This role provides an opportunity to design and implement effective processes within a fast‐growing organization.
Reports to:
Global Supply Chain Lead / CTS Asset Lead

Key Accountabilities and Responsibilities:

• Drives the development of tailored clinical trial supply strategies aligned with the relevant clinical trial protocol and in compliance with GxP requirements, local regulations and argenx processes;
• Creates and maintains complete and accurate clinical supply plan (‘CTS Agreement’) for clinical studies in alignment with protocol requirements, key study parameters and milestones, patient projections;
• Ensures availability of IMP for our patients in collaboration with our external stakeholders;
• Responsible for management of external clinical trial supply vendors and distributors:
• Plan and coordinate the execution and release of IMP packaging runs
• Support label and packaging design and blinding strategy development as necessary
• Review distribution plan and monitor adherence
• Create and maintain updated IMP demand planning;
• Manage potential unexpected challenges occurring related to supply chain activities (Temperature excursion, damaged material, unblinded situations, etc…);
• Represents CTS (Clinical Trial Supply) in the Clinical Study Team;
• Drives the processes necessary for IRT set-up, conduct and close-out from a clinical trial supplies perspective;
• Develops and executes detailed clinical trial supply project plans in close collaboration with stakeholders;
• Drives the development of a study specific pharmacy manual and other relevant guides in close collaboration with Clinical Study Team and CMC team;
• Actively track drug inventory and visualizes active drug consumption versus projected forecast;
• Contributes to planning and organization of global product manufacturing activities;
• Responsible for collecting, registering and archiving information and documents in accordance with the applicable GxP guidelines for clinical studies (TMF, eTMF);
• Contributes as needed to CTS process development (label development, IRT, SOPs, ..);
• Responsible to consolidate, maintain and track the clinical trial budget.

Qualifications and Skills:

• Master’s degree in a scientific discipline or equivalent through education and experience;
• Minimum 4 years’ experience in field of clinical trial supplies;
• Knowledge of GxP regulatory requirements; Quality conscience attitude
• Excellent organization and planning skills;
• Strong communication skills and able to build relationship with internal and external stakeholders – team player with an analytical mindset and delivery-oriented focus;
• Flexible attitude in combination with a proactive mindset; Can do mentality;
• Working knowledge with MS Office package;
• Fluent in English – our working language.

Offer:

• A competitive salary package with extensive benefits;
• Work in a cross functional environment, with many different internal and external stakeholders;
• A position in a human-sized, dynamic and rapidly growing biotech company;Opportunity to contribute to the continued build out of the supply chain team.
• #LI-Hybrid

• Drives the development of tailored clinical trial supply strategies aligned with the relevant clinical trial protocol and in compliance with GxP requirements, local regulations and argenx processes;
• Creates and maintains complete and accurate clinical supply plan (‘CTS Agreement’) for clinical studies in alignment with protocol requirements, key study parameters and milestones, patient projections;
• Ensures availability of IMP for our patients in collaboration with our external stakeholders;
• Responsible for management of external clinical trial supply vendors and distributors:
• Plan and coordinate the execution and release of IMP packaging runs
• Support label and packaging design and blinding strategy development as necessary
• Review distribution plan and monitor adherence
• Create and maintain updated IMP demand planning;
• Manage potential unexpected challenges occurring related to supply chain activities (Temperature excursion, damaged material, unblinded situations, etc…);
• Represents CTS (Clinical Trial Supply) in the Clinical Study Team;
• Drives the processes necessary for IRT set-up, conduct and close-out from a clinical trial supplies perspective;
• Develops and executes detailed clinical trial supply project plans in close collaboration with stakeholders;
• Drives the development of a study specific pharmacy manual and other relevant guides in close collaboration with Clinical Study Team and CMC team;
• Actively track drug inventory and visualizes active drug consumption versus projected forecast;
• Contributes to planning and organization of global product manufacturing activities;
• Responsible for collecting, registering and archiving information and documents in accordance with the applicable GxP guidelines for clinical studies (TMF, eTMF);
• Contributes as needed to CTS process development (label development, IRT, SOPs, ..);
• Responsible to consolidate, maintain and track the clinical trial budget