Our challenge. Your impact.
We aspire to be the patient-preferred global biopharmaceutical leader transforming the lives of people with severe diseases and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, who want to make a difference and deliver results.
At the earliest date possible we search for a Clinical Supply Lead.
NATURE & SCOPE
The Clinical Supply Lead is accountable for the efficient and on time supply delivery of assigned programs (compounds/molecules).
He/she actively drives study and packaging designs as well as supply chain optimization, advising on supply options, risks and costs for the compound portfolio.
He/she acts as a strong and visible partner for Technical and Clinical Development Organizations, connecting PVU, PVP and PVO for all pre-commercialization supply topics, while also providing full visibility on the clinical development plans and the compound information to the CTS department.
As program matrix leader, he/she is responsible for the trial supply design, and he/she oversees the trial supply set-up and execution, through other functions within CTS, GDL and QA.
Scope: All clinical trials (phase 1-4) + Compassionate Use Programs (EAP/NPP/MAP) + Investigator Initiated Trials/Studies (IIT/ISS) with CTS involvement.
Products: All UCB products + Alliance programs
Clinical Supply Chain design and demand planning:
- Identifies needs for new packaging’s and communicate them to the Clinical Trial Supply Operations for further development
- Drives sourcing strategy decisions for comparators and packaging.
- Defines an appropriate supply strategy (through modulization if appropriate) to:
- Leads impact assessment of product changes on CTS department and activities
- Plans the demand on the mid and long term horizon. Consolidates the compound demand and ensures manufacturing capacity
- Defines compound as well as study supply budgets, and manages financial processes for compound supplies
- Acts as CTS interface for the Technical Lead, Clinical Program Director and Clinical Operations Lead, fostering a close collaboration to:
Program Matrix leadership:
- Coaches/supports Clinical Supply Set-Up Managers and Clinical Supply Planners in the resolution of the compound/study related issues, as well as in the selection of the appropriate supply strategy during the set-up and maintenance phases of the studies
- Guarantees optimal handover of information/knowledge to the CSSM for the start of the study set-up activities
- Leads and maintains structured oversight on clinical trials (forecasted, under set-up and ongoing) per compound to ensure no supply chain disruption and adequate budget, providing guidance and support to other functions from CTS, GDL and QA as needed
Master Degree in sciences and a minimum of 5 years of CTS-relevant experience (in biologics or pharmaceutical manufacturing/packaging, and/or clinical supply chain).
In depth knowledge on clinical trial conduct, effective networking with both Development and Technical Operations.
Drives decision making, while balancing supply risks and costs.