Sr. Specialist, Clinical Supplies Project Manager Protocol (Hybrid)

Job Description

The Global Clinical Supply (GCS) organization is accountable for managing the end-to-end integrated clinical supply chain across the full Companys Research and Development Division 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 and/or change management related topics.

• Responsible and accountable for establishing the timelines for clinicalsupplyneedsper study and providingthe signal for sourcing manufacturing packaging and distributionfor the Company development products and non-Company 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 non-pipeline activities.

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

• Utilization of key technological tools and systems for GCS planning such as SWMS Veeva MEDS MyLearning SAP and Microsoft Applications and PowerApps.

• Change Control Processing. Effective collaboration within GCS Planning and the Comparator Planning team to ensure that Change Requests are created and moved through the process steps in an efficient way in accordance with established GCS planning SOPs/BPs and QMS Topic 3.4 Change Control Procedures and Work Instructions.

• 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 required.

• 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 cross-functional teams senior management external vendors and clinical sites. Strong negotiation influencing and relationship-building 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 data-driven decisions to optimize supply chain processes.

• Flexibility & Adaptability: Demonstrates ability to thrive in a fast-paced 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:

• Results-orientation with the proven ability to execute on collaborative projects and develop subject matter expertise

• Knowledge of order management supply chain operations and document control

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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