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Program Manager, Clinical Supply Chain Management

Company

ABBVIE
Address , , Il
Employment type FULL_TIME
Salary
Expires 2023-07-18
Posted at 1 year ago
Job Description
Purpose:
The Program Manager, Clinical Supply Chain Management’s primary responsibility is to manage the clinical supply chain for early phase 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:
  • Participate and contribute to Product Presentation and Device Strategy Team (PPDST) meetings
  • Represent the clinical supply chain on Integrated Evidence Strategy Teams (IESTs)
  • Matrix management of Clinical Supply Project Managers (CSPMs) supporting the global clinical supply chain
  • Define and manage external budget for compounds (comparators, co-meds, over-encapsulation, depots, and importation costs)
  • Define and implement a global clinical supply strategy, in conjunction with mentor or experienced Drug Supply Manager
  • Allocate bulk drug product to CSPMs, minimizing wastage
  • Define API and drug product requirements and delivery dates to support the clinical supply chain
  • Lead the recovery of clinical supplies during a product recall, support the evaluation and approval of non-medical complaints (NMCs), exception reports and recalls.
  • 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


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

Job Grades are determined by the country in which the payroll is based.


AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.