Purpose

The Program Manager, Clinical Supply Chain Management’s primary responsibility is to manage the clinical supply chain for early phase (uncomplicated) compounds. The completion of clinical trials is the rate-limiting step for filing of new drug applications and, ultimately, to product commercialization. The on-time initiation, uninterrupted conduct, and completion of clinical studies is dependent on the timely delivery of clinical supplies of top quality to the clinical sites.

Responsibilities

• Define and implement a global clinical supply strategy, in conjunction with mentor or experienced Drug Supply Manager
• Ensure all clinical supplies (early phase, affiliate studies, and IIS) are delivered on time, on budget and of top quality with no studies interrupted or delayed due to clinical supplies
• Define and manage external budget for compounds (comparators, co-meds, over-encapsulation, depots, and importation costs)
• Represent the clinical supply chain on Integrated Evidence Strategy Teams (IESTs)
• Participate and contribute to Product Presentation and Device Strategy Team (PPDST) meetings
• Define API and drug product requirements and delivery dates to support the clinical supply chain
• Matrix management of Clinical Supply Project Managers (CSPMs) supporting the global clinical supply chain
• Allocate bulk drug product to CSPMs, minimizing wastage
• Lead the recovery of clinical supplies during a product recall, support the evaluation and approval of non-medical complaints (NMCs), exception reports and recalls