This position will be responsible for all operational activities supporting clinical trials ensuring forecasting, timely manufacture, packaging, labeling and distribution of global clinical supplies to support world-wide conduct of Phase 1-4 studies. The incumbent will lead operational development activities for active, placebo comparator, and co-admin products and guide development teams on all Clinical Supply related operational issues. In addition, this position will assist in the integration of process activities with strategic globalization efforts to improve speed of development and is responsible for administrative budget and project expenditures supporting global CSO programs.
- Oversee department-initiated contract manufacturing, packaging, labeling, and distribution operations for clinical studies to meet business and strategic goals; ensure compliance with cGMPs and Daiichi Sankyo standards, coordinating with Regulatory and Quality functions as required.
- Lead CSO operational development activities, such as outsourced vendor management responsibilities, batch record review and approval, label generation and approval; advise development teams on CSO-related issues, such as clinical packaging development and labeling; collaborate with Regulatory Affairs and QA to develop and execute registration strategy and bioequivalence programs.
- Preparation and maintenance of forecasts and ensure transparency in global CSO communications within Daiichi Sankyo and with vendors/partners. Monitor IXRS-drug supply issues, site shipment frequencies, importations, etc. Prioritize activities in response to changes in clinical needs and corporate objectives.
- Assist in the establishment and improvement of Standard Operating Procedures (SOPs) and guidelines related to clinical supply management and operations, including production planning and scheduling, inventory management, labeling, distribution, transportation, disposition of returned/unused material, etc.
- Assist in the evaluation and actively pursue business operational process improvements globally and regionally to increase efficiency to accelerate clinical development in a global environment, without sacrificing quality or compliance with cGMPs.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Bachelor's Degree in Pharmaceutical Science or related field required
- Master's Degree in Pharmaceutical Science or related field preferred
- PhD preferred
- 10 or More Years related experience, including project management, Clinical Supply Operations management, IXRS functional knowledge and knowledge of pharmaceutical development. preferred
Ability to travel up to 30% Overnight travel will be required to go to other global CSO locations and outsourcing vendors.