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 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 Protocol Clinical Supplies Project Manager (Protocol CSPM) serves as the primary protocol-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 development related meetings (i.e., Clinical Trial Teams). Working independently, the Protocol CSPM designs strategic and operational plans for all clinical supply activities associated with their assigned clinical studies. The incumbent is expected to have an understanding of the concepts of drug development, clinical research, and/or clinical supply chain, as well as interpersonal skills with a demonstrated ability to negotiate with key stakeholder groups and drive/influence results in a dynamic environment.

Primary activities include, but are not limited to:

• Interacts closely with key partner organizations (as the GCS Planning protocol 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 protocol(s).

• Responsible and accountable for establishing the timelines for clinical supply needs per protocol and providing the signal for sourcing, labeling, packaging, and distribution for development products and non-company marketed products.

• 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.

• 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.

• Works directly in the SAP system to establish a consolidated, visible forecast for all study product needs (i.e. 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 identifying significant supply risks associated with clinical finished good activities in addition to clinical supply issue escalation within their protocol(s) (and subsequent manage thereof) to GCS Leadership.

• Support the collection of clinical supply chain metrics to describe business health and the identification of areas for operational improvement.

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

• Leads others to solve complex problems; takes a broad perspective to identify innovative solutions

• Acts as a resource for colleagues across multiple areas

• Challenges current processes, methodologies or technologies and recommends alternative solutions

• Lead teams or projects; motivates other team members; promotes value of working together as a team and relationship building, using the diverse perspectives of others to generate ideas

• Manages large or multiple small  projects with moderate resource requirements, risk and/or complexity

Required Experience and Skills:

• Bachelor’s degree in a scientific, business, or related discipline required, MS/MBA preferred.

• At least 8 years of experience in project management.

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

• Understanding of material requirements planning (MRP) systems and demand planning principles

• Strong organizational, time management and problem solving skills

• Results oriented with the proven ability to execute on collaborative projects and develop subject matter expertise Exceptional  written and verbal communication and relationship skills along with high personal integrity, credibility, and energy.

• Ability to prioritize tasks and initiatives appropriately to mitigate supply risks.

• Advanced proficiency in Microsoft Excel, PowerPoint, and Word.

• Experience with change management and lead