Our client, a rapidly growing Pharmaceutical organization in Boston, is seeking an expereince AD, Clinical Supply Chain to lead and manage all clinical supply activity, including packaging, labeling and distribution of investigational product and serve as a key contributor in the commercialization of assets. This individual will serve as a key connection point between Clinical Operations, Pharmaceutical Development and Technical Operations. The organization has roughly 325 employees and an exciting pipeline, including a commercial product and a number of clinical stage trials. This will be the first direct report under the Director of Supply Chain and be instrumental in growing out clinical supply chain space.
Responsibilities:
- Design and execute packaging and labeling campaigns
- Translate clinical protocol information into demand forecasts and supply strategies
- Develop campaign timelines and budgets
- Develop IRT supply specifications and clinical label texts
- Manage CMOs to deliver study material on time\ budget
- Manage IP distribution through study closeout and drug destruction
- Lead process improvement initiatives and author\ revise clinical supply SOPs
- Enable successful clinical trials using supply chain management processes (Plan, Source, Make, Deliver, and Return)
- Manage relationships with packaging and labeling CMOs and track vendor performance. Managing Contracts, Expenses, Invoices, Annual Budgets
- Serve as a primary interviewee in regulatory inspections\ audits as needed
Qualifications:
- Bachelor Degree required
- 10+ years of relevant clinical supply chain experience
- Solid understanding of cGMPs and the clinical research process
- Expertise investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring and experience implementation of Corrective Actions and Preventive Actions (CAPA) resulting from these investigations
- Experience managing contract packaging for commercial products and clinical supplies and labeling organizations (strongly preferred)
- Experience with IRT systems and ex-US clinical supplies management (considered a plus)