• Plan, coordinate and communicate the clinical trial supply activities to optimal quality, time and budget at trial and project level. 


• Oversee the complete supply chain of IMP for assigned clinical trials and projects.

Scope: All projects and clinical trials (phase 1-4) performed under the responsibility of Global Clinical Development, GMA, Phase 1 and IIS (for clinical).

Products: All products of UCB and Schwarz Pharma legacy

• In case acting as Clinical Supply Coordinator for CTS for set up, maintenance, return, destruction and archiving of multinational Phase 1-4 clinical trials; refer to the Job Description of Clinical Supply Coordinator.


• Define and consolidate a supply strategy to ensure adequate and sufficient forecasting of drug product for an entire project.


• Compile the trial budgets into a project related budget and provide regular updates to the budget forecast.


• Represent CTS during TST and CST meetings and ensure CTS needs and expectations are met (e.g. drug product shelf-life, CTS related timelines, bulk availability, IVRS and country selection ...) and be able to influence decisions taken during those meetings.


• Address the need for CMC related activities (e.g. development of formulation, stability program, shelf life extension etc.).


• Provide leadership for the Clinical Supply Coordinators/Associates for the assigned project without direct supervision to ensure no supply chain disruption for all project related trials.


• Provide mentorship to junior CTS Planning colleagues.


• Ability to travel domestically or internationally for business reasons on an as needed basis.


• Improve the processes of trial and project related activities.


• Communicate with internal and external customers and colleagues.


• Contribute to the creation, implementation and training of SOPs.


• Drive CTS-related general improvements at a systematic level supported by the Local Head of CTS Planning.

• Master degree in sciences and with minimum 4 years of CTS relevant experience in pharmaceutical production, clinical trials and/or supply chain.


• Demonstrated experience in project management (min. 3 years).


• Or Bachelor degree in sciences and with minimum 7 years of CTS relevant experience in pharmaceutical production, clinical trials and/or supply chain.


• Knowledge of legal requirements (at international, European and national levels) in terms of I.M.P. (Annex 13 to EU GMP, CFR, ICH, EU GCP, labelling requirements and design).

• Ability to work without supervision and to set-up and meet timelines.


• Ability to work under pressure and within an international team environment.


• Demonstrated project management skills and ability to prioritize, organize and plan with minimum supervision. 


• Ability to influence and lead teams and deliver expected outcomes without direct supervision.


• Ability to translate complex information into clear and concise communication.


• Excellent verbal and written communication, negotiation and presentation skills.


• Ability to set-up and manage virtual meeting (i.e. tele-conferences).


• Fluent oral and written English skills and computer proficiency.


• Ability to act as a CTS consultant to customers, internal and external colleagues.


• Ability to mentor internal CTS Planning colleagues.

• Ability to solve issues, to assess risks and prevent issues for assigned projects.


• Address areas for improvements, propose creative solutions, support development and implementation of improvements at systematic level.

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