Senior Manager, Clinical Supply Chain Logistics

Xeris Pharmaceuticals•Chicago, IL

8h•Onsite

About The Position

The Senior Manager, Clinical Supply Chain Logistics, is responsible for the oversight and distribution of all goods in support of the company’s clinical programs and will lead efforts to ensure timely supply of clinical trial materials. This is a critical leadership role that will bridge the gap between research and commercialization by ensuring investigational medicinal products (IMPs) and ancillary supplies are delivered to clinical trial sites around the world in a safe, accurate, timely, and compliant manner. A key aspect of this position will be to work closely with the Clinical team to develop an understanding of clinical trial protocols and to translate those into precise forecasting models. Based upon the demand and forecasting models, this individual is responsible for working internally within PDTO to develop and oversee a clinical supply plan. This role is critical to setting up a robust clinical supply model to support national and international studies. This position will lead the process for delivery and develop the optimal levels of inventories across all sites and support packaging and labeling activities. This role requires a strong ability to collaborate with multiple functions, including Clinical, Regulatory, Quality, Finance, as well as internal functions within PDTO. Must have experience with the import and export of clinical materials.

Requirements

Bachelors in Biological Sciences or related fields.
Minimum of 8 years of industry experience with at least 5 years in a distribution/logistics environment in the healthcare industry.
Expert knowledge of GxP regulations, strong organizational and forecasting skills, and proven vendor and cross-functional team management.
Experience with clinical supply chain planning.
Experience with IRT, clinical asset tracking, working with and without ERP systems.
Experience with labeling requirements for domestic and international studies.
Experience working closely with Manufacturing, Project Management, functional team leaders, clinical teams, contract manufacturing partners and/or cold chain shippers and logistics providers.

Nice To Haves

Experience with controlled substances and Hazardous Materials is considered a plus.
Experience with cold chain products is strongly preferred.

Responsibilities

Accountable for building a clinical supply plan to provide input to manufacturing, labeling, and forecasting supply activities across internal and external stakeholders.
Track inventory levels and expiry dating of clinical goods and component inventory across multiple sites.
Collaborate with clinical teams and other internal/external stakeholders to develop demand forecasts based on trial protocols and timelines.
Coordinate logistics activities across multiple sites and with multiple partners.
Plans and oversees packaging and labeling operations both internally and with CMOs as required to support the clinical supply plan.
Participate/lead investigations in close collaboration with Quality, as applicable.
Identify issues and/or risks with meeting clinical supply requirements and suggest solutions to meet timelines.
Continuously evaluate and improve supply chain planning business processes to optimize operations.