The Clinical Supplies Manager is a key member of the clinical development team and assists in the oversight of all aspects of clinical supply planning, forecasting, capacity planning, labeling/packaging, distribution and risk management for all Xeris clinical products/clinical trials. This role works closely with Clinical Operations, Clinical Research, CMC, Regulatory Affairs, Supply Chain, Quality, Finance, Manufacturing, contracted CROs, and external clinical supply vendors to forecast and manage clinical supply and ancillary supply needs and timelines for all clinical trials.
ESSENTIAL JOB FUNCTIONS:
Enables the on-time delivery of clinical supplies across the Xeris portfolio.
Supports Clinical Project Managers by developing and updating Study Supply Plans, managing various work streams with key service providers, and working with internal departments to progress clinical supply projects.
Manages clinical supply activities for on-going and new clinical trials, expiry date management, ensuring on-time delivery returns and reconciliations. Collaborates cross-functionality with internal and external partners to determine clinical supply needs throughout the life of the study.
Oversight of the forecasting, planning, labeling/packaging and distribution of clinical supplies and/or ancillary supplies for all clinical trials.
Generates clinical demand forecasts, conduct supply availability analysis, and communicate results to key stakeholders. Oversight of forecasting initial individual study and resupply drug needs, and coordinates supply strategies with internal Supply Chain and packaging suppliers.
Assists in the development of the overall secondary packaging and labeling strategy to support individual clinical trials (global and domestic, all phases) in accordance with study and program timelines. Coordinates changes to labeling/packaging schedules for clinical drug products based on study progress and or any changes with the study plans.
Coordinates clinical labeling/packing supplier qualifications with Quality Assurance.
Works closely with internal colleagues and external partners to proactively manage clinical and ancillary supply and comparator drug inventories as required. Maintains inventories and provides study, region and country inventories for all Xeris clinical products.
Oversees and actively manages relationships with contract clinical labeling/packaging/distribution vendors to ensure production and inventory targets are communicated and met, managing depot/site distribution/stocking requirements and expiration/retest date requirements. Communicates accurate lead time requirements to clinical packaging/distribution suppliers and Project management, and Internal Supply Chain.
Works with Director Clinical Programs to review and develop procedures and processes to manage the growth of clinical supplies and the increasing number of clinical trials being conducted by Xeris.
Collaborates with internal Regulatory department to ensure label proofs are generated for internal approval GCP QA per approved protocol. Responsible for ensuring non-used labels are reconciled.
Supports department budget development activities. Raises issues or concerns to manager with recommendations for resolution.
Reviews and approves monthly invoices for assigned clinical trial activities, reviewing for accuracy and tracking discrepancies to resolution.
Contributes to the review, development, and revision of department SOPs.
Communicates necessary information to all appropriate departments for the purpose of initiating the quoting process.
Prepares formal quotes for requested services.
Solicits, reviews, and manages CMO quotations and work orders. Initiates purchase orders for work to be completed and reviewed.
BS/BA degree in Pharmacy or related field is required. MS or PharmD highly beneficial.
Minimum 5 years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. Creation of Supply Planning tools is preferred.
Good understanding of Pharmaceutical Development, Quality Assurance, and Regulatory (domestic and international).
Solid knowledge of clinical supply planning, manufacturing, packaging, and labeling.
Experience in managing third-party contract clinical supply operations.
Experience managing multiple vendors per project required.
Import/export knowledge desirable.
Excellent communication, negotiating, and computer skills.
Strong team orientation.
Internal Number: 2019-1085
About Xeris Pharmaceuticals
Xeris is a specialty pharmaceutical company leveraging its novel technology technology platforms to develop and commercialize ready-to-use, room-temperature stable injectable and infusible drug formulations. The company’s proprietary XeriSol™ and XeriJect™ formulation technologies are being evaluated for the subcutaneous (SC) and intramuscular (IM) delivery of highly-concentrated, non-aqueous, ready-to-use formulations of peptides, small molecules, proteins, and antibodies using commercially available syringes, auto-injectors, multi-dose pens, and infusion pumps. XeriSol™ and XeriJect™ have the potential to offer distinct advantages over existing formulations of marketed and development-stage products, including eliminating the need for reconstitution, enabling long-term room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. These attributes may lead to products that are easier to use by patients, caregivers, and health practitioners and reduce costs for payers and the healthcare system.