Associate Director, Clinical Supply 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 our Company's 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 product development 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 clinical supply needs per study and providing the signal for sourcing, manufacturing, packaging, and distribution for our Company's development products and our Company's non-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.

• Participates in cross-functional initiatives/projects as either the project lead or stakeholder participant.

• Responsible and accountable for utilizing key tools/systems such as IRT & Microsoft PowerApps, SWMS, Veeva, MEDS, MyLearning, and other Microsoft Applications in the management of clinical supplies for assigned studies.

• 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) System development and User Acceptance Testing (UAT) for assigned studies. Participates in initiation and timely processing of change controls through collaboration with GCS Planning and other cross functional stakeholders and in accordance with established GCS planning SOPs/BPs and QMS Topic 3.4 Change Control Procedures and Work Instructions.

• Participates in authoring and timely processing of deviation records as well as supports deviation investigations as required.

• Participates in critical non-pipeline and compliance activities in support of GCS Planning (e.g., process improvement initiatives, subject matter expert roles, SOP/BP development/maintenance, cross functional projects, etc.)

• Participates in supporting regulatory agency inspections for assigned trials as required.

• 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 o