Clinical Supply Specialist (Contract)

Reporting to the Director, Supply Chain, this role is expected to work closely within the Supply Chain team, as well as cross-functional groups such as Clinical Operations and Quality.

- Supports the development and execution of Clinical Supply strategies for all 4DMT's Phase 1/2/3 investigational drug products and ancillaries

- Coordinate and track bulk drug orders to ensure adherence to pre-defined supply and resupply timelines

- Monitor site inventory on a daily basis; coordinate and and track drug shipments to ensure uninterrupted supply

- Supports drug product inventory management and distribution in partnership with 4DMT's clinical partners; evaluates drug utilization versus forecast considering country requirements and logistical timeline

- Maintains study and depot-level accountability and reconciliation documentation to support regulatory compliance and study closeout

- Tracks and resolves study and depot level temperature excursions. Provide routine reporting of drug wastage due to these excursions

- Maintain traceable documentation to support GXP activities

- Degree in biological or life sciences, pharmacy or medicine (or international equivalent). A minimum of 3 years in the pharmaceutical industry or relevant work experience and a minimum of 1 year in Clinical Supply Chain.

- Familiar in the daily management and operations of a Clinical Supply Chain inclusive of bulk management, distribution, and maintaining study blinds across multiple investigational products

- Experienced with Interactive Response Technology - IRT systems for inventory management and resupply

- Working knowledge of regulations relating to clinical labeling, packaging, and distribution activities; working knowledge of GMP/GCP/GLP regulations

- Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines

- Positive attitude with a strong desire for continuous learning