Senior Director, E2E Clinical Supply Network Plan & Systems

工作内容

In this role, you will be responsible, together with your team, to drive the optimal global planning or a portfolio of R&D products from an end to end, value stream agnostic perspective (biologics, small molecule, vaccines). The function holder is responsible for the leadership and direction for the worldwide end-to-end clinical supply from raw material, to Drug Substance, to Drug Product, to forecasting & capacity planning for internal and external sites. In addition, this position is responsible drug availability with appropriate balancing of inventory and distribution costs, managing key customer and vendor interfaces and driving strategic improvement programs across the JRD portfolio as well as IRT(interactive response technology) strategies.

• Lead the E2E supply chain planning performance and IRT performance in alignment with targets and metrics for CSC.
• Developing and implementing a supply plan to support the JRD portfolio and support success in conducting clinical trials of the highest quality and reliability.
• Ensuring timely completion of E2E planning activities in the Monthly Planning Cycle to stakeholders/business partners
• Identifying and mitigating proactively potential product supply issues for API and DP and partner with the CSO for kit.
  

Interacting collaboratively and proactively across CSC (S&OP, inventory,

• strategic capacity management, clinical supply operations, etc.), key business partners (finance, JSC planning, external partnerships, procurement, BTDS, CPDS, vaccines manufacturing, quality, etc.) and senior leaders in CSC.
• Providing ownership of systems operations and new system introductions, deployment for the E2E product planning processes, master data harmonization and system data.
• Providing leadership and governance for the IRT strategy, processes, and vendor management.
• Lead Therapeutic Area team design leads responsible for setting up the IRT system and adapting it as needed to supply specific trial requirements and adjust as information changes.
• Adapt the IRT, inventory and supply strategy in view of changes in participating countries and sites and trial protocols
• In collaboration with the Clinical Supply Operations Heads, set up a balanced supply plan which considers operations efficiency, inventory, and successful dose. Lead internal and external planning teams to deploy monthly, the MPS, manufacturing Master Production Schedule (MPS) to ensure that customer requirements are met, while facilitating efficient manufacturing operations in alignment with the KPI’s for the value stream
• Proactively identify constraints or potential issues and develop options for resolution.
• Independent problem-solving and decision-making are expected and required. This includes internal and external issue escalation resolution and corrective action planning.
• Provide strategic, technical, and operational leadership, manage budget and resource allocation in the global planning organization
• Lead teams responsible for planning supply for clinical supplies from raw materials to finished product distribution utilizing inventory and modeling tools to ensure visibility, cost control and on time supply.
• Translating clinical study demand in batch demand from packaged clinical supplies to raw materials
• Manage and improve overage at Drug Substance and Drug Product level
• Global capacity planning and MPS for each operation in the clinical supply chain
• Managing master data, planning of orders in SAP
• Sourcing of co-meds, comparator, and DP outside of DPDS
• Track planning performance and plan adherence
• Adapt the planning, inventory and supply strategy in view of changes in demand
• Day to day issue resolution with OTD of supply
• Management of comparator supply and budget approvals
• Provide strategic leadership to critical improvement initiatives,
• With the Supply Chain Systems group, establish full transparency and oversight across the entire supply chain
• Define and implement Supply Planning initiatives to increase speed & flexibility of the supply chain, through the implementation of lean/value stream and PEx planning principles
• Partner effectively with stakeholders & partners, e.g.
• Clinical Supply Chain leaders
• JSC Global Planning, VSL leadership and Launch Management
• Global Development Operations including Strategic Partnerships
• BTDS, CPDS, vaccines make organizations
• Responsible for key strategic programs to improve planning and field inventory management within Clinical Supply Chain by defining program scope and objectives and leading implementation
• Develop excellent working relationships with the other groups within the Clinical Supply chain, and especially with the Clinical Supplies Operations team.
• CSC Management Lead on Quality Escalations for drug that has been released into the field.
• Member of the Clinical Supply Chain Leadership Team.
• Responsible for new talent acquisition for the CSC through GOLD, BRIDGES and other talent programs.
• All clinical supplies for all phases of clinical trials
• Biologics, small molecules, vaccines
  

Qualifications

Education and Experience Requirements:

• A degree in life sciences, engineering, or supply chain. 12-15 years of experience in development or operations; MBA preferable
• Proven leadership track in pharmaceutical development or global supply chain management, having led a global or multisite team
• Demonstrated knowledge and understanding of clinical and clinical operations, or equivalent experience in managing a global complex customer base facing significant operational change
• Demonstrated knowledge and understanding of clinical supplies (overall process, operational and supply chain aspects), or equivalent understanding in managing a supply chain with high demand variability and complex product portfolio
• Expertise planning systems, simulation tools, or ERP planning systems, is a plus
• Strong operational and planning skills. Proven track record in managing changing priorities, short timelines in a structured and organized way
• Excellent people management and leadership skills. Proven ability to drive technical and personal competency development of a team with frequent rotations
  

Critical Competencies

• Strategic influencing: Able to assertively manage complex customer interface
• Masters complexity: Handles high change in product portfolio and demand, in a global setting
• High sense of urgency: Quickly prioritizes, effectively deals with time critical patient supply risks
• Excels at people and organization development, and competency management
• Big Picture Orientation with Attention to Details: Instills a culture of analytical rigor, but is always able to provide the broader business perspective
• Staff: Manages a global team of 25+ persons
• Location: flexible at any of the Janssen sites
• Travel: Up to 20%
• Language requirement: English
  

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location

United States-New Jersey-Titusville-1125 Trenton Harbourton Road

Other Locations

North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Switzerland-Allschwil, Belgium-Antwerp-Beerse

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2206056614W