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Associate Director, Global Clinical Supply Chain Operations

2 months ago

Plainsboro, New Jersey, United States Genmab Full time
About the Role

We are seeking an experienced Associate Director to join our Global Clinical Supply Chain Operations team in Copenhagen or Princeton. As a key member of our team, you will be responsible for driving the strategic direction and development of our clinical supply chain operations.

Key Responsibilities:
  • Global Clinical Supply Chain Planning:
    • Develop and implement standards for clinical supply chain planning, ensuring compliance and support for overall strategic direction.
    • Drive the development and maintenance of SOPs for the Global Clinical Supply Chain Planning area, including implementation of new regulations.
    • Lead continuous improvement initiatives and changes related to the overall GCDS team and GCDS Planning strategic plans.
    • Ensure strong collaboration throughout all Global Clinical Supply Chain (Planning, Operations, Systems, and Strategy & Innovation) teams.
    • Stakeholder management and collaboration at an internal company leadership level, including Development Operations, CMC, Project Portfolio Management, Medical, and enabling functions, as well as external partners.
    • Implement lessons learned from the portfolio through initiatives, process changes, and ways of working.
    • Provide SME knowledge support.
    • Responsible for oversight and resolution of deviations, CAPAs, and change controls in connection to Clinical Drug Supply Planning.
    • Responsible for inspection and audit as representative Global Clinical Supply Chain.
    • Drive Inspection and Audit preparation and execution.
    • Responsible to be compliant with Genmab's quality system.
  • People Management:
    • Manage Global Clinical Supply Chain Team - Planning team members (directly or in-matrix manner).
    • Drive leadership and guidance to Global Clinical Supply Chain - Planning members.
    • Point of contact for escalations related to Drug Supply Planning, and other GCDS areas as needed.
    • Supervise, coach, and mentor colleagues during onboarding and maintenance of training.
  • Global Clinical Supply Chain Project/Trial Management:
    • Obtain Project/Trial specific information to initiate drug supply strategic planning and execution, and maintain information on changing clinical development plan.
    • Develop, implement, and maintain strategical operational plans and approaches for drug supply to clinical trials.
    • Ensure continuous and consistent communication between Global Clinical Supply Chain functions (Planning, Operations, System, and Strategy & Innovation) to ensure no stock-outs and timely delivery of clinical trial supplies.
    • Ensure the reduction of wastage and target high levels of cost-savings per projects.
    • Identify risks for delays for projects/programs and trials and possible mitigations (contingency plans and new/additional scenarios) that may impact clinical drug supply.
    • Create and maintain program/project and trial IMP/AMP forecast and demand plans throughout the trial lifecycle.
    • Aggregate IMP/AMP forecast and demands on project/program level.
    • Maintain all project/program trial level inventory and ensuring no stock out situations.
    • Create and maintain program/project and trial budget forecast throughout the trial lifecycle.
    • Collaboration with Sr. Management, CMC, CDTL, DPM, and CTT Members.
    • Lead and participate in cross-functional teams (CDTs, CSTs, CTTs, CMC) and support strategic cross-functional collaboration (i.e., project/program and trials).
    • Lead Clinical Project Supply Team discussion.
    • Participate in regulatory discussions in relation to IMP/AMP.
    • Manage project/trial specific planning documentation (i.e., drug supply plan, milestone tracking, IMP manual, etc.).
    • Ensure GxP compliance & regulatory guideline compliance during all drug supply planning tasks, activities, and deliverables.