- The Clinical Supply Manager will oversee activities related to ensuring drug supply management for all on-going and planned world-wide clinical trials (Phase 1-3).
- The Clinical Supply Manager will be responsible of clinical trial supply planning, labeling, packaging, inventory management and distribution to ensure timely delivery of clinical supplies to clinical sites.
EDUCATION AND EXPERIENCE
- Ph.D. or M.S. in Chemistry, Biology, Biochemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field.
- 10 year-experience with at least 5 year-experience in the pharmaceutical clinical trial supply chain operations, including global clinical trial drug management, such as planning, sourcing, inventory control and logistics.
- Experience managing the drug supply chain for global Phase 1 to 3 studies including knowledge of International packaging regulations, import/export licensure and drug depot utilization.
- Hands-on experience in developing and managing integrated supply chain IT support systems.
ROLE and RESPONSIBILITIES
- Manage clinical supply chain operations with outside CROs and CMOs including forecasting for all clinical trials, working closely and collaboratively with Clinical Operations, Regulatory Affairs and other R&D functions to design appropriate planning, labeling, packaging and distribution configurations.
- Coordinate outsourcing of labeling, packaging and on-time distribution of clinical trial supply to world-wide clinical sites: ensure the scheduling and timely delivery of all necessary clinical supply materials, such as bulk drug, label and packaging inserts, randomization schemes, packaging and shipping configurations, labeling and distribution plans of all portfolio projects.
- Ensure that all documentation concerning CTS (La belling, packaging, distribution, reconciliation) is available complete and correct.
- Ensure that all supplies are controlled and distributed in accordance with GMP, GLP, GCP and GDP regulations.
- Interact with the Clinical CRO and IVRS on supplies, replenishments, returns and destructions.
- Review and archive any blinded documentation until the end of the clinical study.
- Monitor clinical trial supply management invoicing by CMO.
- Represent clinical trial supply chain function on internal and external cross functional teams.
- Advanced knowledge of labeling, packaging, inventory management and distribution procedures (particularly IWRS systems) related to the management of clinical trial supplies
- Deep understanding of drug development and clinical development processes especially clinical trial planning and execution.
- Experience in managing CMOs with clinical trial services.
- Experience in auditing and managing supply chain and drug packing CMOs.
- Knowledge of GMP, GLP, GCP and GDP compliance requirements.
- Knowledge of state of the art industry supply chain control systems including IT packages
- Knowledge of business related areas: project management, contracts, invoicing, and finance
- Excellent planning, communication, negotiation and organization skills.
- Complete fluency in English is a must. French is a plus.