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Supply Chain Study Lead
2 months ago
We are seeking a highly skilled Supply Chain Study Lead to join our team at VONQ. As a key member of our supply chain team, you will be responsible for providing tactical oversight of the end-to-end supply chain for assigned GSK R&D clinical studies.
Key Responsibilities:- Develop and maintain detailed demand and supply plans for investigational medicines to ensure timely delivery to patients.
- Collaborate with cross-functional study teams to understand clinical requirements and over-arching study objectives.
- Proactively engage with clinical study teams to ensure supply options and risks are explored and agreed.
- Challenges planning information at the study level and helps resolve logistical conflicts to ensure clinical supplies are off the critical path.
- Develops, implements, and maintains the investigational product (IP) demand plans for assigned studies.
- Develops, implements, and maintains the IP supply plan for assigned studies.
- Accountable for contributing to the supply planning (PK) meeting as part of the monthly D&OP cycle.
- Monitors expiry dating of clinical supplies and coordinates expiry extensions or replenishment strategies and destructions if extensions are not possible.
- Accountable for ensuring that label content is defined and the data is set-up in the appropriate system(s) and liaising with relevant groups on pack design and pack component suitability.
- Accountable for ensuring appropriate Interactive Response Technology (IRT) contract and setup is in place.
- Bachelor's degree in Logistics, Supply Chain, or a related field.
- Knowledgeable of clinical trial study designs and approaches and their implications for supply chain.
- Knowledgeable in the management of investigational product supplies and experience in inventory management.
- Demonstrated working knowledge of supply chain and planning principles.
- Ability to manage multiple and complex projects that require strong problem-solving skills and creative or innovative thought to address global supply problems.
- Knowledgeable in regulatory requirements including Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs) and the Trial Master File.
- Demonstrated understanding of the drug development process.
- Knowledgeable and experienced in working with Interactive Response Technology (IRT) systems, especially with respect to supply management and patient randomization.
- Strong organizational and planning skills coupled with strong written and oral communication skills.
- Demonstrated capability to work with aggressive and changing timelines and with limited information and without defined absolutes.
- Knowledge of the technical challenges with regards to investigational product packaging and labeling.
- Bachelor's degree in Logistics/Supply Chain.
- APICS Certification, Black or Green Belt, Lean Sigma Certification.
- Strong analytical skills.
- Ability to work in a matrix organization.
- Strong influencing skills.
- Ability to simplify complex processes.
- Effective verbal and written communication skills, including presentation skills.
- Knowledge of enterprise resource planning systems.
- Sense of urgency, flexibility, and accountability.
- Enterprise thinker (end-to-end supply orientation, cross-functional team spirit, sharing of good practices within the network).
- Proven planning and organizational skills.
- Ability to lead and drive change.