Our client is a clinical‐stage biopharmaceutical company that is creating and developing a deep 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 our Product Supply Team, we are looking for a 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 organisation.
Key Accountabilities and Responsibilities:
- CTSM represents product supply in the Clinical Study Team;
- CTSM drives the development of tailored clinical trial supply strategies aligned with the relevant clinical
trial protocol; creates and maintains complete and accurate clinical supply demand for clinical studies
in alignment with protocol requirements, key study parameters and milestones, patient projections;
contributes to set‐up of IRT systems;
- Develops and executes detailed clinical trial supply project plans in close collaboration with stakeholders
and in compliance with GxP requirements, local regulations and argenx processes;
- Drives the development of a study specific pharmacy manual 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; provides logistics
support to the manufacturing team;
- Responsible for management of external clinical trial supply vendors and distributors;
- Responsible to consolidate, maintain and track the clinical trial budget.