Independently develop, plan, and optimize global IMP distribution strategies for assigned clinical studies across all phases.
Lead set‑up and alignment of distribution concepts, including country- and site-specific requirements.
Support the design and implementation of the IRT set‑up related to IMP distribution strategy (e.g., depot structure, resupply logic, shipment triggers).
Manage, coordinate, and oversee external Distribution Partners (DPs), ensuring compliance with contractually agreed service levels.
Act as primary distribution contact within the global CTSU Trial Team, ensuring alignment with Clinical Operations, Supply Chain, Quality, and other stakeholders.
Independently analyze and assess temperature excursions related to IMP logistics and storage.
Perform initial evaluation, documentation, and classification of deviations and complaints in the applicable IT systems.
Independently report, process, and close deviations and CAPAs in accordance with the Boehringer Ingelheim Quality System.
Experience Required:
Several years of experience in the pharmaceutical industry with a focus on international clinical IMPs supply, as well as a good understanding of the clinical development processes. Very good understanding of product-specific properties and product quality. In-depth knowledge of international regulatory, legal and customs regulations and experience in the field of import/export.
Education:
Bachelor's degree in science or distribution management with several years of experience in the pharmaceutical or similarly regulated industry in a relevant field.
