Manager, Clinical Supply Chain (P)

Insmed Incorporated
6dHybrid

About The Position

We’re looking for a Manager, Clinical Supply Chain on the Clinical Supply Chain & Logistics team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Head of Clinical Supply Chain & Logistics, you’ll be responsible for managing inventory and demand plans for assigned studies and projects. What You'll Do: In this role, you’ll have the opportunity to work cross-functionally with Supply Chain & Logistics customers both internal and external to the organization and is expected to be collaborative and communicative.

Requirements

  • You have a Bachelor’s degree along with 4 years of experience in 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.

Nice To Haves

  • MS Project and other computer software demand & supply related systems are a plus.

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
  • Support IRT system design and UAT requirements for assigned studies
  • 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
  • Assist manager in developing study or program level supply assessments
  • 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.

Benefits

  • Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
  • Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
  • 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
  • Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
  • Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
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