Program Manager, Clinical Supply Chain Management

About the role

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

Qualifications

• Bachelor's Degree or higher in Pharmacy or Science
• 5-7+ years' experience in the pharmaceutical industry
• Demonstrated understanding of the overall drug development process
• Experience in project management, planning, forecasting, budgeting
• Excellent interpersonal, team, and leadership skills
• Sound knowledge of GxP

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.