Senior Manager, Clinical Supply Chain – EnDevor – Massachusetts, USA
Seeking an experienced and talented individual who thrives in a dynamic, fast-paced, team-oriented and collaborative environment. The successful candidate will manage all aspects of the clinical drug supply chain, including creation, execution and maintenance of the clinical drug supply strategy and budget management. The candidate will collaborate closely with the internal clinical supply chain team, and will directly manage drug product and label/pack/distribution CMOs, to ensure uninterrupted drug supply for global clinical trials.
: Collaborate closely with the broader clinical supply chain team, including clinical operations, manufacturing, quality and program management personnel, to develop and maintain efficient supply chain plans.
: Interpret study protocols and clinical development plans to create long range clinical study drug demand forecasts.
: Manage supply chain CMOs to develop labeling/packaging materials, and for the manufacture, storage and cold chain distribution of clinical trial materials.
: Assist with the management of drug product CMOs for sterile fill/lyophilization of biologics.
: Identify, evaluate, request proposals from, audit and select appropriate Contract Manufacturing Organizations.
: Five+ years of experience in managing global clinical supply chain in the Pharmaceutical and/or Biotech industry.
: Experience managing US and EU clinical supply chain CMOs, and strong understanding of regulatory requirements and guidelines governing labeling, packaging and distribution of clinical trial materials.
: Experience implementing IXRS systems, and managing IXRS vendors.
: Experience working with drug product CMOs, and strong understanding of GMPs and regulatory requirements governing clinical drug product manufacturing.
: Ability to strategically plan, organize and manage multiple projects simultaneously.
: Strong interpersonal and organizational communication skills, including planning and execution of meetings and presentations.
: Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, etc.)