Program Manager/Director, Clinical Supply Chain Management

Job Description
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