Manager, Clinical Supply Chain

About the role

We're seeking a Manager, Clinical Supply Chain to join our Clinical Supply Chain & Logistics team. Reporting to the Senior Director, Head of Clinical Supply Chain & Logistics, you'll manage inventory and demand plans for assigned studies and projects. You'll collaborate cross-functionally with Supply Chain & Logistics customers both internally and externally.

Responsibilities

• Assist in developing demand and supply plans for assigned studies and/or programs
• Assist in overall production planning from raw material manufacturing through finished good demand planning and scenario planning
• Serve as main point of contact for clinical supply on designated studies and projects
• Day-to-day management of primary and secondary inventory
• Coordinate with and manage external packaging, labeling and distribution vendors
• Represent Supply Chain & Logistics at cross-functional study level meetings to ensure timely updates and information to assigned studies/projects
• Communicate relevant project information to internal and external stakeholders
• Develop and present slide decks, coordinate drafting of reports, and edit documents for preparation of business development activities
• Develop and approve clinical labels through collaboration with Regulatory CMC, Clinical Operations and Quality Assurance
• Identify, report, manage and mitigate risks in the clinical supply chain
• Provide regular updates to the TMF as per regulatory requirements
• Understand and contribute to the budget process
• Collaborate with internal stakeholders to ensure supply availability at each node within the supply chain
• Coordinate with Supplier Relationship Management for clinical suppliers, including maintaining key performance metrics and budget/invoice tracking
• Coordinate with Insmed contracted clinical supply organizations to appropriately disposition clinical supply material
• Draft SOPs, WPs and procedures for clinical trial material packaging, labeling, and distribution to ensure compliance with cGxP requirements
• Work closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable results
• Ability to identify risks in process management and develop a solution-based approach that is operationally achievable

Requirements

• Bachelor’s degree along with 4 years of experience in drug development, clinical supply chain management and/or clinical manufacturing operations
• Proficient with Microsoft Applications (Excel, PowerPoint, Word)
• Experience working with and/or managing external vendors
• Working knowledge of GMP, GCP and ICH guidelines
• Strong teamwork and collaboration skills
• Strong ability to handle multiple projects simultaneously
• Acts with a sense of urgency