Sr. Manager, Clinical Supply Chain

MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.

Job Summary:

As a Clinical Supply Chain Sr. Manager, you will play a pivotal role in ensuring efficient delivery of high-quality clinical trial supplies for all early and late-stage MannKind clinical trials worldwide. Your responsibilities will include managing the packaging, labelling, distribution, and destruction of clinical supplies. You will work collaboratively with internal quality assurance, packaging technology, program management, clinical manufacturing, manufacturing supply chain, and internal manufacturing teams on overall trial demand. Externally, you will manage CMO/CRO partners responsible for kitting, labeling, distribution, site management, and IMP destruction, ensuring compliance throughout the supply chain

Job 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.
  
  

Job 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.
  
  

Pay Range: $128,000 - $192,000 per year