Clinical Supply Management

Major tasks and responsibilities of position

• Manage the supply chain, China and/or global, in order to guarantee simultaneous worldwide availability of study medication in clinical trial by determining, assigning and monitoring all contributions needed from technical and clinical interface partners.
• Implement and supervise a faultless and economic production process in order to ensure GXP- and worldwide regulatory compliance as well as lack of any mix-up risk by painstaking planning of chemical synthesis, manufacture of bulk pharmaceutical product and packaging and labeling of patient medication.
• Establish and supervise a faultless and economic distribution process on a study level in order to guarantee simultaneous medication availability to clinical sites by developing a comprehensive distribution concept with multiple internal and external partners and using state-of-the-art technologies such as Interactive Voice/Web response systems, Statistical Simulation tools and logistical IT systems.
• Perform extensive sourcing of external services (drug manufacture, packaging, labeling and distribution) in order to ensure availability of study medication by selecting, qualifying, ordering and monitoring contractors in worldwide locations in compliance with Bayer’s sourcing directives.
• Build and maintain networks with stakeholders in Clinical Development, Clinical Operations, Clinical Pharmacology, Pharmaceutical Development, Chemical Development, Analytical Development, Legal, Procurement and others in order to maximize the efficiency of the supply chain of investigational medicinal products by establishing best practice processes in an environment that is inherently complex through high regulation (GXP, Customs, Compliance Directives).
• Represent Global Clinical Supply (GCS) in CMC Development teams, Global Project teams, Clinical Development teams and Clinical Study teams in order to ensure GCS deliverables by displaying solution orientation, team-player attitudes and strength in peer leadership

Qualifications

• Minimum academic education as pharmacist but a graduate degree, particularly in Europe and US, is a plus. (equivalent education can be applied if vast experience in drug development is available); Working experience in a multi national company in China in drug development, preferably in the management of clinical supply, with a proven successful track record (showing excellence in the technical understanding of drug development); Strong Leadership and project management skills; Profound knowledge of and practical experience with international GXP regulations; Excellent communication and negotiation skills; Excellent written and oral English and Chinese skills; Profound awareness of cultural habits in the Americas, Europe, China, and Asia/Pacific; and High resilience to pressure resulting from timelines, complexity and politics.