Clinical Supply Chain Manager

Role Summary

The Clinical Supply Chain Manager will provide global program direction and subject matter expertise in clinical trial material supply management. S/he will work with internal and external teams to develop clinical trial material supply chain strategy and ensure effectiveness of execution. In accordance with Zenas’ outsourcing model for drug development, the incumbent will oversee the planning and execution of outsourced clinical trial material supply chain activities and will work proactively with external partners to define project scope, mitigate risks, and ensure successful delivery with regard to technical quality, timelines and budget. S/he will work within a cross-functional development team environment to support Zenas’ short-, intermediate- and long-term strategic goals.

Responsibilities

• Interact effectively and transparently with internal stakeholders in the areas of Clinical Operations, Clinical Development, Program Management, Drug Product Development and Manufacturing, Analytical Development and Quality Control, Quality Assurance, Regulatory Affairs, Strategic Sourcing and Vendor Management, and external business partners.
• Develop and maintain clinical trial material study/program forecasts and supply plans to support clinical trial initiation and on-going clinical trials by collaborating with Zenas functional groups, CRO and CTM vendors.
• Oversee operations related to labeling and packaging of clinical trial materials. In partnership with QA, support deviation investigation and associated CAPAs for clinical trial materials release for clinical use.
• Manage distribution, return, and destruction activities, track clinical trial material inventory and expiry dates, and coordinate import/export requirements related to the clinical study.
• Coordinate over-labeling date extension activities.
• Oversee direct-to-patient plans for clinical studies.
• Lead development of global label text and translations for clinical studies working with the internal Zenas functional groups, CRO and CTM vendors.
• Contribute to the development of clinical trial IRTs by providing the clinical supplies and depot user requirement specifications and performing the user acceptance testing.
• Budget/scope management related to clinical trial material supply chain.
• Pro-actively collaborate with internal stakeholders and external business partners to achieve group, departmental and corporate goals.
• Ensure well-organized, clear, and complete records of all activities across areas of responsibility.
• Manage and execute personnel qualification/training program.

Qualifications

• BS/BA in science or a related field with a minimum of 5 years hands-on working experience in clinical trial material supply management in the biopharmaceutical industry is required.
• Must have hands-on working experience in global IRT systems and conducting placebo-controlled trials.
• Must have hands-on working experience with CDMOs/CROs in clinical trial material supply management and with global business partners
• Knowledge and experience in managing early and late phase clinical trial material supply
• Familiar with current regulatory requirements related to clinical trial material supply.
• Highly organized, exceptional attention to detail, and strong proficiency in documentation skills.
• Strong communication and follow-up skills
• Must work well in a small team setting, with ability to work independently and collaboratively with cross functional departments.
• Ability to work flexible business hours to communicate with global business partners (up to 20% of time).