Role Summary
Sr. Manager, Clinical Supply Chain at MannKind Corporation, focusing on delivering high-quality clinical trial supplies across all phases worldwide. You will oversee packaging, labeling, distribution, and destruction of clinical materials, collaborating with internal teams and external CMO/CRO partners to ensure compliant and timely supply across trials.
Responsibilities
- Oversee all operational aspects of the clinical supply chain.
- Review clinical protocols and design proper supply chain strategies.
- Collaborate with the clinical team to configure, set up and support Interactive Response Technology (IRT) Systems.
- Develop global SOPs and processes for trial materials globally.
- Solve study/project level technical and business issues of trial materials.
- Oversee packaging and labeling activities for clinical trial materials in compliance with Good Manufacturing Practices (GMP).
- Manage global supply inventory depot strategy, from start to implementation.
- Provide consistent CMC and Core Study team updates on supply progress and strategy, communicating challenges and collaborating on solutions to mitigate trial risks.
- Ensure compliance with the ETMF documentation.
- Support any required regulatory documentation requests.
- Observe all Company, Health, Safety and Environmental guidelines.
Qualifications
- Bachelor’s degree in supply chain management, logistics, science and technology, or another related field.
- 5-7 years of experience in clinical supply chain.
- Strong organizational skills with diligence and accuracy in inventory tracking.
- Proficient in inventory management and clinical planning tools (ERP systems, MS Excel, RTSM systems, IXRS/IRT, etc.).
- Experience with reconciling inventory and managing IMP destructions worldwide.
- Ability to analyze production schedules and forecast material demand.
- Effective communication and collaboration skills with cross-functional teams.
- Strong time-management skills and the ability to prioritize tasks in a challenging environment.
- Knowledge of Medidata and/or Microsoft Dynamic 365 a plus.
- Ensure compliance with the ETMF documentation.
Skills
- Clinical supply chain management
- Inventory management and planning tools
- GMP compliance
- Cross-functional collaboration
- IRT/RSRM systems familiarity
- Regulatory documentation support
Education
- Bachelor’s degree in supply chain management, logistics, science and technology, or related field
Additional Requirements
- Travel requirements not specified
- Physical demands not specified