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Main Purpose and Objectives of Position:

The Sr. Director, Clinical Supply Strategy is accountable for partnering with drug development teams, clinical, CMC, and the broader Product Delivery (PD) Organization to speed delivery of clinical trial materials to patients and enable innovative supply chain solutions. This is accomplished by planning and scheduling via a Material Requirements Planning (MRP) system (SAP) and communication with key business partners.

The Sr. Director provides strategic leadership and technical expertise in all aspects of clinical trial (CT) supply planning and execution for the molecules/trials they are responsible. They are accountable for the delivery of clinical trial material to support clinical development in line with asset/clinical development plans. They are a critical communication point to business leaders for development of innovative supply strategies and status of CT supply execution. They are accountable for influencing the capabilities, processes, metrics, and operations of the supply planning and PD function.

Key Responsibilities:

Clinical Supply Strategies

• Develop and implement supply plans for supported molecules to ensure:
  • plans are robust with key risks identified and mitigated
  • capability & capacity across CT supply chain are optimized (includes packaging, distribution, sites).
  • supply chain principles are leveraged
  • supply plans are translated into the MRP System (e.g. SAP, including CT-WIN)
• Ensure establishment of a sourcing strategy for commercial products to support the clinical plan.
• Understand how supply strategy and demand forecast affects PD and Business Unit/Research budgets, communicate cost considerations for trial supply options as an input into decision making, and proactively manage communication around changes that impact the PD budget for a trial.
• Deliver the supply strategy for supported molecules:
  • manage risks through implementation of risk mitigation and contingency plans
  • resolve issues through creative problem solving and managing appropriate communication/escalation
  • adapt the supply strategy as drivers change through execution
• Ensure CT Material Operations Teams for supported molecules are driving strong and effective supply planning, execution, and communication across PD and CM&C.
• Ensure the priority, clinical strategy, and supply strategy for supported molecules/trials are communicational and understood by PD and CM&C organization.
• Support due diligence assessment of opportunities as it relates to CT supply and integration of necessary activities upon deal approvals.

Influence Clinical Development

• Provide supply chain options to support clinical development strategies with clearly articulated benefits, risks and trade-offs.
• Develop productive partnerships with clinical development teams and leadership in order to drive effective communication, build trust and credibility, and improve knowledge of PD planning requirements/process.
• Influence clinical strategy and plans to establish an efficient, robust, executable supply strategy.
• Be the key point of contact within PD for clinical and development leadership as it relates to communication, escalation and problem solving.

CT Supply Chain Principles, Capability, and Organizational Impact

• Develop deep knowledge of supply chain principles and strategies, supply chain tools and process, and functional construct associated with supply chain and leverage that technical depth to develop and influence asset/trial/department strategy resulting in robust, reliable, efficient, and where needed, innovative, clinical supply strategies and plans/execution.
• Influence, lead, and support strategic solutions to increase innovation, efficiency, and productivity within supply planning and PD, including identifying areas for strategic investment.
• Leverage external environment, practices, and technology to improve PD supply planning principles, strategies, tools, and processes.
• Ensure robust supply chain metrics are in place to monitor performance and drive PD operational excellence, integrating across clinical and CM&C.
• Maintain and continuously improve PD business processes, tools, guidance and training.
• Support continuous learning and rapidly institutionalize best practices.
• Identify and influence improved solutions for clinical trial patients and sites.
• Build supply chain expertise and/or awareness in others who work in and interface with PD.
• Champion a commitment to quality and safety.

People Development and Capability Building

• Train, coach, and mentor supply planning staff to deepen their supply chain expertise, improve their communication and partnership with clinical, CM&C, and the broader PD organization, and drive effective CT material operations teams. This may be through direct or indirect reporting relationships, as assigned.
• Develop future leaders and supply chain experts in PD.
• Support a culture that fosters inclusion, innovation, and judgement-based decision making.
• Create, develop, influence and/or manage an agile organization that continuously meets the needs of a changing portfolio
• If assigned, recruit, develop, and retain an operationally capable workforce skilled in CT supply and its application in clinical development.

Educational Requirements:

Bachelor’s degree or 5+ years work experience in clinical research or clinical supply chain

Experience Requirements:

• 10+ years of experience in two or more of the following areas: drug development, clinical drug development, CT material, CMC, quality or commercial manufacturing
• Demonstrated understanding of clinical drug development and clinical trial management/execution
• Exceptional critical thinking, strategy development, and decision-making skills
• Ability to develop strategies and make decisions in the absence of an obvious answer/approach
• Exceptional partnership and communication skills – both internal and external
• Exceptional knowledge of investigational product requirements – GCP and GMP
• Demonstrated understanding of external environment, practices, and technology within CT supply chain.

License/Certificate Requirements: N/A

Language Requirements: Must be fluent in English

Additional Preferences:

• Licenses or Certifications (eg APICS, Supply Chain Certificate (via MBA or university program), PM)
• >3 years of experience within roles across the clinical trial supply chain
• Experience as a supervisor, preferably leading an organization
• Experience leading cross-functional teams
• Advanced degree (e.g. MSc, Pharm D, Ph D) and/or degree in health care, sciences, or supply chain filed
• A deep understanding of quality systems and operating in a regulated environment.

Additional Information/Requirements:

• Work outside of core hours may be required to support the portfolio across the globe
• Minimal travel may be required (<10%), both domestic and international

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