The selected candidate will be responsible for study supply leadership to ensure timely planning and execution of supply strategy for continued supply of clinical finished goods (supply drugs) to patients. Furthermore, he will be in charge for optimal clinical trial supply strategy in terms of packaging design, pro-active planning following a risk-based approach. In this role the successful candidate reports to Head of CMC, located in the US.
Your responsibilities include:
Supply Chain Management: Develop and implement clinical supply chain strategies, including packaging, labeling, distribution, and return or destruction of clinical supplies.
Collaboration: Work closely with clinical operations, project management, and manufacturing teams to establish clinical supply plans.
Forecasting: Predict the need for clinical supplies and ensure timely and cost-effective delivery.
Inventory Management: Monitor and manage inventory levels to prevent stockouts or overstocking.
Compliance: Ensure compliance with regulatory guidelines and Good Manufacturing Practice (GMP) standards.
Vendor Management: Participate in the selection of vendors and the negotiation of contracts.
Documentation: Review and approve clinical supply documents such as packaging instructions and shipping documents.
Risk Management: Implement strategies to mitigate supply chain disruption
BSc degree in Supply Chain Management, Logistics, Business Administration, or relevant field or Graduate degree (i.e. Ph.D). APICS certification or coursework is desired.
Minimum of 10 years’ experience in drug supply chain oncology.
Thorough understanding of GXPs governing the manufacture of pharmaceutical drug products and conduct of routine clinical trials distribution.
Extensive experience in clinical supply management including logistics (labeling, packaging, distribution, expiries), inventory tracking, and managing IRT systems.
Must be knowledgeable in US, EU, and ROW clinical supply labeling requirements and the QP review/release/certification process for European clinical supplies.
Experience with both ambient and cold chain products.
Must be able to effectively manage multiple activities and problem-solve to achieve business needs.
Strong communication skills, able to work independently and collaborate with key internal and external stakeholders
Excellent project management skills.
Dynamic and energetic, hands-on approach to challenges.
Business travel to various company offices, suppliers, and partners as required.
The opportunity to contribute to the development of a successful clinical program in oncology.
A role in a pioneering environment as part of a dynamic biotech company on the rise.
A collegial atmosphere characterized by a driven and supportive team.
Flexible work schedules with the option to work remotely.
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