Associate Director, Clinical Supply Project Manager - Program (Hybrid)

Job Description

The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company Research Laboratories (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. 

The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact representing the GCS Planning organization to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.  Working independently, the Program CSPM designs strategic and operational plans for all clinical supply activities associated with the clinical studies in their assigned compound(s)/ program(s). 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:

• Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines,  strategies and other related topics for all clinical supplies across all assigned program(s). 

• Responsible and accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s). 

• Works directly in the SAP system to establish a consolidated, visible forecast for all products used within the assigned program(s) (i.e. Bulk Drug Product).  

• Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within assigned program(s). 

• Responsible for identifying significant supply risks associated with clinical bulk activities in addition to serving in a lead role for clinical supply issue escalation within their program(s) (and subsequent manage thereof) to GCS Leadership.  

• Responsible for the clinical supply budget for respective program(s) and for supporting all protocol and program cost estimates requested by Product Development Teams. 

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

• Support the collection of clinical supply chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise. 

• 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 &