DRUG SUPPLY MANAGER Job in Princeton 08540, New Jersey US
Manages project teams within Drug Supply Management (DSM) to support the clinical supply needs of multiple projects, typically within the same therapeutic area. Develops projects, monitors budgets, issues manufacturing and packaging requests and prioritizes work. Manages and updates supply component of the Drug Development Plan. Sets the supply plan and forecasts for drug program and corresponding protocols. Sets strategic direction for drug supply outsourcing needs. Nurtures relationships to make outsourcing options available. Prepares packaging options for negotiations with clinical leader. Manages IVRS development activities. Fully understands the clinical study and clinical supply processes viewed by peers as a leaderwith a high level of respectability and complete knowledge of processes and strategies. Develops and maintains effective interfaces with key customers external and internal. Creates close collaboration to meet key milestones in the clinical supply process including decisions on clinical supply strategies and designs, delivery of comparators and approved documentation to support clinical supply production. Demonstrates leadership skills by driving for continuous improvement and encouraging and supporting collaboration across departments. In particular, leads teams to ensure timely delivery of quality clinical supplies to support clinical programs. Demonstrates a strong consistent display of team behavior by actively participating in project related teams and is accountable for supply related component. Has a high level of problem solving skills and uses them to monitor key milestones in the global clinical supply process. Advises Clinical Supply Operations (CSO) and Clinical management of resource constraints and recommends strategies which will influence the ability of CSO to meet existing or anticipated demands. Recommends and implements ways to improve the efficiency of clinical supply process.
Bachelor’s degree in Pharmacy or related science plus 5 - 10 years of experience in the pharmaceutical industry with a focus in clinical supplies. Has thorough understanding of the drug supply, distribution and packaging process. Demonstrated ability to work with and manage people teams in a culturally diverse, complex, changing environment for the timely delivery of clinical supplies. Demonstrated ability to effectively communicate and persuade others to accomplish clinical supply goals and objectives. Demonstrated ability to develop others. Demonstrated ability to forecast and allocate resources to manage clinical supply programs with focus on meeting the program objectives. Demonstrated ability to apply organization’s operating philosophy and operate within policies and procedures. Demonstrated problem solving skills. Demonstrated broad computer program literacy, including MS Word and Excel. Excellent knowledge of the global clinical supply and clinical study processes. of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices GDPs and local country drug shipment regulations. Project planning skills to make optimum use of resources and to meet timelines. Knowledge of effective communication and how to impact and influence people. Excellent interpersonal skills. Self motivated with a proven ability to organize project activity to meet multiple project timelines.