Essential Job Functions
- Responsible for developing all elements of drug supply inventory management and planning activities including key raw materials, regulatory starting materials, drug substance intermediates, API, drug products, and packaged goods
- Coordinate and maintain the CMC manufacturing supply chain network and operations for the commercial and 3PL business interface.
- Responsible for the overall logistics management elements for both clinical and commercial supply and delivery
- Coordinate drug supply delivery timelines with CMC Manufacturing, Commercial and Clinical; includes Packaging, Labeling, and Distribution CRO's
- Monitor and track global supply chain inventory for clinical studies; maintain and coordinate manufacturing with commercial forecast requirements, demand planning.
- Maintain close communications with all internal supply chain groups to ensure the adequate supply of product throughout the duration of multiple clinical studies and commercial forecasts
- Serve as knowledgeable resource for managers throughout the organization on issues related to investigational and commercial products
- Support financial planning for commercial demand and global clinical supplies, including budgeting, forecasting, and strategic planning activities and drug distribution with finance
- Other duties as requested by supervisor
Job Requirements
- Bachelor's degree, or equivalent, preferably in a scientific or pharmaceutical discipline
- 5+ years of prior experience in a pharmaceutical, biotech, and supply chain logistics environment preferred
- Fundamental knowledge of inventory management, database management, and forecasting systemsfor both Clinical Trial and Commercial supply sourcing networks
- Working knowledge of demand planning, supply chain network coordination, and third party logistics and serialization processes
- Proactively identifying potential issues, develop mitigating actions and notifying appropriate personnel in a timely manner
- Hold a fundamental understanding of ICH guidelines, GXP's, 21 CFR and Annex 13 requirements as well as import/export and customs requirements
- General working knowledge of essential computer applications (i.e. MS Word, Excel, PowerPoint, MS Project, Smart Sheets) and a working knowledge of IVRS systems
- Ability to multi-task
- Excellent verbal and written communication skills
The base range for a Senior Manager is $157,000- $167,000 and Associate Director is $180,000 - $190,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.