Job Description:Job PurposeThe 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.
Essential Job Functions- 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.
Skills and Qualifications- Bachelors in Biological Sciences or related fields.
- Senior Manager must have a minimum of 8 years of industry experience with at least 5 years in a distribution/logistics environment in the healthcare industry.
- Experience with controlled substances and Hazardous Materials is considered a plus.
- 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 cold chain products is strongly preferred.
- 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.
- Competencies: Strategic Thinking, Problem Solving, Teamwork and Collaboration, Independent Judgement, Professionalism, Written & Verbal Communication skills, Customer Service focus, Attention to Detail, Results-oriented, Focus on High Quality & Accuracy, Adaptability, Organizational Skills, MS Suite
Working Conditions- Position may require periodic evening/weekend work, and periodic overnight travel, as necessary to fulfill obligations.
- This position is located in Xeris' Chicago office.
The anticipated base salary range for this position is $155,750 - $213,600.
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We are committed to offering competitive compensation. Starting pay is determined based on a variety of factors, including the role, job-related knowledge, skills, experience, education, internal equity, market data, and the location of the role, where applicable.
