Sr. Specialist, Clinical Supply Project Manager - Protocol (Hybrid)

The Global Clinical Supply (GCS) organization is accountable for managing the endtoend integrated clinical supply chain across our Companys Research Laboratories portfolio of clinical trials. GCS is accountable for the planning sourcing labeling packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.

Working independently the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities associated with clinical supplies for their assigned studies which could vary in complexity. This individual serves as the primary GCS point of contact to stakeholders both internal and external to GCS and serves as the GCS spokesperson at clinical development related meetings (i.e. Clinical Trial Teams) and productdevelopment related meetings. The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (i.e. clinical development CMC supply chain & human health) and balancing needs of patients & ensuring stable supply of product.

Primary activities include but are not limited to:

• Participates as a key stakeholder on the Clinical Trial Teams (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical supplies.

• Interacts with key partner organizations such as clinical development regulatory quality and other supply chain areas to address clinical supply related topics.

• Responsible and accountable for establishing the timelines for clinicalsupplyneedsper study and providingthe signal for sourcing manufacturing packaging and distribution for our Companys development products and nonour Companys marketed products.

• Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and prepares analyses and/or develops mitigation strategies for review with clinical partners and senior leaders.

• Works directly in the SAP system to establish a consolidated visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).

• Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support critical CMC activities.

• Responsible for authoring the Clinical Supplies section of the study protocol as well as preparation and presentation of the clinical supplies information at Investigator Meetings for assigned protocols.

• Support the collection of clinical supply chain metrics and/or participate in critical nonpipeline activities.

• Participate in Interactive Voice Response (IVR) Systemdevelopment and User Acceptance Testing (UAT) for assigned studies.

• Mentors new team members and supports staff development as needed

• Demonstrates high capability to solve unstructured problems make informed risk decisions considering both technical & business risks & influence portfolio decisions with facts and data

• Demonstrates ability to balance strategy with ability for tactical execution and has strong ownership & accountability of assigned work

• Focus on Customers & Patients.

• Make rapid disciplined decisions.

• Demonstrates Ethics & Integrity.

Required Experience and Skills:

• Bachelors Degree in scientific business or related discipline .

• At least 5 years of experience in project management

• At least 5 years of experience in planning scheduling coordination and processing of supply chain activities or the equivalent

• Excellent Communication & Interpersonal Skills: ability to effectively communicate with stakeholders at various levels including crossfunctional teams senior management external vendors and clinical sites. Strong negotiation influencing and relationshipbuilding skills to ensure alignment and collaboration in the supply planning process.

• Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management.

• Technical Proficiency: familiarity with supply chain systems and software (e.g. SAP or Oracle) and demand planning principles as well as Microsoft Excel PowerPoint and Word

• Strong Analytical & Problem Solving Skills: ability to analyze complex data identify trends and make datadriven decisions to optimize supply chain processes.

• Flexibility & Adaptability: Demonstrates ability to thrive in a fastpaced and dynamic environment with the capability to adapt quickly to changing business needs and priorities.

• Detail Oriented & Organized: strong attention to detail in managing complex supply chain activities; ability to multitask prioritize tasks and meet tight deadlines.

• Continuous Improvement Mindset: Proactive approach to identify process inefficiencies develop solutions and drive continuous improvement initiatives within the clinical supply planning function.

• Proficiency in using supply chain management systems and software including experience with ERP systems (e.g. SAP) demand planning tools and inventory management systems.

• Proven record in project / portfolio management.

• Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is highly desirable.

Preferred Experience and Skills:

• Resultsorientation with the proven ability to execute on collaborative projects and develop subject matter expertise

• Knowledge of order management supply chain operations and document control