The Manager/Associate Director, Clinical Supply Management is responsible for implementing and managing all aspects of the clinical supply chain in support of Immune Designs’ and its partners’ clinical needs. This position will act as the interface between the Supply Chain, Clinical Operations, Medical Affairs, Manufacturing, and Quality to ensure timely availability of finished drug products, combination products, comparator products, and matching placebos for use in global clinical studies. This role will oversee shipment and drug return logistical activities as well as over-labeling by interacting with internal and external customers and suppliers to accomplish project objectives. This role will represent Supply Chain in all relevant Clinical and CMC meetings and work with Clinical Operations to help develop investigational medicinal product (IMP) forecasts, distribution, and return drug plans. The Clinical Supply Chain Manager also monitors clinical site inventory levels and provides feedback to the Clinical Operations team regarding expiry and re-supply. This role may also assist in the set up and management of an Interactive Response Technology (IRT) system for drug supply management. The candidate for this position will be expected to have Global Clinical Supply Management experience, working closely with internal and external parties to develop budgets and timelines as well as maintaining supplier and partner relationships.
The Clinical Trial Manager performs project management activities and provides daily management of multiple study activities. The CTM is responsible for setting up and managing functional aspects of studies including Clinical Research Organization (CRO) selection/oversight, investigational product, lab sample, and financial accountability. The CTM may also be responsible for monitoring clinical sites or to assist in oversight of monitoring to verify that the rights and well‑being of human subjects are protected; that the reported trial data are accurate, complete, and verifiable from source documents; and that the conduct of the clinical trial is in adherence to protocol, GCP/ICH, and SOPs.