Manages the efficient flow of goods, services, and information throughout the clinical supply chain, including product order management and global distribution. Builds relationships with and acts as a key resource and escalation point for internal customers, distributors, and suppliers. Contributes to the creation of strategy for clinical drug supply; translates strategic objectives into plans for team execution. Works within clinical drug supply as well as cross-functionally to develop consistent practices. Knowledgeable of departmental and industry best practices. Participates in larger supply chain projects as required. Develop manufacturing/inventory plan based on demand. Routinely identify risks in supply chain, recommend mitigation plans to management, and implement solutions. Ensure resources are in place to support new product launches/clinical studies and supply chain projects. Manage/support cross-functional projects such as cross-functional process/system integration. Build processes that are scalable for future growth.
Maintain Study Supply Continuity
·Accountable for availability and distribution of FG for protocol
·Monitor FG supply performance
·Develop and maintain FG demand plans and update relevant systems
·Setup and maintain FG distribution; monitor day to day activities and maintain budget
·Manage Investigations and Events in Trackwise
Study Single Point of Contact
·Serve as the single point of contact for the protocol (KPI, reporting, enrollment, country list updates, etc.)
·Participate in the protocol SMT for distribution and FG
Drive FG packaging strategy (including labelling)
Manage FG item creation for drug (including design); FGI item creation as needed
Communicate requirements with Clinical Asset Planner(s)
·Coordinate with Asset Planner on initial protocol development
·Communicate FG demand to Asset Planner
Import License Management
·Accountable for import licenses for protocol
·Maintain and track import licenses
Maintain Study Inspection Readiness
·Finalize protocol IMP accountability
·Represent CDS as primary interviewee at regulatory inspections as needed
Development of the IRT supply strategy (resupply parameters, DNS, DND)
Serve as backup to other Supply Managers
Exerts considerable influence on the overall objectives of planning and the programs. Provides input to not just specific planning decisions but also broader cross-functional decisions. Errors in judgment or failure to achieve results may have revenue and/or clinical trial milestone implications and may have an effect on manufacturing schedules, inventory levels, program milestones, documentation accuracy. Errors could result in coordination delays across functions. Errors could result in Supply Management being noncompliant with internal processes and program/corporate milestones/targets.
Leads cross-functional program teams within Global Operations to meet all supply chain requirements and other strategic or continuous improvement goals
Effective project leader with the right blend of granularity and the ability to see the big picture. Accountable for the development and implementation of solutions. Ability to lead cross functional teams and influence without authority. Organizational maturity and excellent judgment required when making decisions. Excels in taking on projects in trouble and bringing them to a successful conclusion.
Communication skills, customer service/focus, relationship management, organized, supply chain knowledge, MS Office suite, project management, conflict management, leadership skills. Linked to years of relevant experience performing at above levels.
Integrated scenario planning, i.e., working out scenarios and implications on supply and demand. Generate multiple supply/ demand scenarios. Implement scenarios using appropriate analytical techniques, reporting capability/turning data into information, knowledge of tools to increase productivity, manage complexity, and improve forecast quality. Ability to gather, organize, and interpret information to generate insight, understanding development, and/or commercial sales processes, supply chain demand and supply planning, scheduling, and quality processes. Ability to manage supply chain performance (interactions and improvements). In-depth and demonstrated supply chain knowledge. Respected subject matter expertise, with business acumen including knowledge of Sales, Marketing, Supply Chain, and Manufacturing. Understanding of the sales and marketing cycle, and long-term planning.