Associate Clinical Supply Chain Director

Role Summary

The Associate Clinical Supplies Director designs, develops, and implements the clinical supplies strategy to ensure appropriate processes are established and clinical supplies deliverables are met for clinical trials. This individual also manages clinical supply activities including planning and forecasting of clinical supply, oversight of clinical packaging, labeling, and distribution operations at contracted manufacturing organizations (CMOs). The AD partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams and ensures timely drug supply for clinical trials.

Responsibilities

• Create and manage clinical forecast plans and budgets related to drug product, and clinical supplies for multiple programs and study levels, based on clinical study protocol and clinical development plans.
• Oversee the labeling, packaging, release, distribution and returns of clinical supplies at external CMOs for the assigned studies, maintaining budget and ensuring that the projects are delivered on time.
• Create global supply strategies, supply plans to support clinical studies; collaborate with Pharmaceutical Operations, Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors to execute the strategies for the clinical studies.
• Manage clinical trial supply to ensure timely IMP production; manage inventory and worldwide distribution activities; ensure uninterrupted supply.
• Manage label development process from generation of the master label text to label printing.
• Lead the development, review and User Acceptance Testing (UAT) of the Interactive Response Technology (IRT) system.
• Co-lead the development of pharmacy documents, manuals and other tools with Clinical Operation team.
• Represent Clinical Supplies function at clinical trial team meetings; communicate plans and timelines to internal and external customers and partners.
• Utilize appropriate software and IT systems (e.g. IRT, MS Office, MS Project, Smartsheets, and others) to effectively manage key project activities.
• Provide coaching and guidance to team members.

Qualifications

• BS/BA degree in related discipline and a minimum of eleven years of related experience; or
• MS/MA degree in related discipline and a minimum of nine years of related experience; or
• Equivalent combination of education and experience.
• Experience in independently leading all aspects of clinical supplies management for Phase I, II and especially Phase III trials as well as investigator sponsored trials (IST).
• Experience with IRT systems for drug supply management.
• Clinical Supply management experience using contract manufacturing companies strongly preferred.

Skills

• Strong knowledge and demonstrated experience in clinical supply management- planning, labeling, packaging and distribution
• Strong initiative and desire to work in a fast-paced team-oriented, and dynamic environment
• Creativity and flexibility in problem solving; work collaboratively as part of a team
• Knowledge of GMP batch record development, review, and approval processes
• Working knowledge of regulations relating to clinical labeling, packaging and distribution activities
• Working knowledge of GMP/GCP/GLP/GDP regulations
• Excellent oral and written communication skills; along with strong demonstrated stakeholder management skills
• Excellent project management and organizational skills; ability to plan and execute multiple on-going projects with ease

Education

• BS/BA degree in related discipline; or
• MS/MA degree in related discipline; or
• Equivalent combination of education and experience.

Additional Requirements

• Working Conditions: 20% travel to vendor sites, team meetings, and/or other offices.