Calithera is seeking a seasoned Clinical Supply Chain Specialist/Manager. Responsible for managing investigational drug, and ancillary supplies (e.g. comparators, co-therapies) for assigned clinical studies, in coordination with Supply Chain, Clinical Operations, CMC, Regulatory, Quality Assurance, and Finance teams. The ideal candidate will have 5+ years of experience in clinical supply chain management, with global experience preferred. The Clinical Supply Chain Specialist or Manager will be assigned at the program and/or study level, with the opportunity to manage multiple studies as the program size warrants. The candidate will have an excellent understanding of the drug development and manufacturing process and be able to independently forecast and manage supply and distribution needs for assigned clinical studies.
Key Duties and Responsibilities
- Effectively manage/oversee investigational drug supply chain for assigned clinical studies, including budget forecasting, procurement/sourcing, forecasting, and import/export activities
- Function as primary contact for Clinical Operations to provide updates to inventory, distribution status, and availability of IMP
- Implement and manage IxRS/IRT systems for assigned clinical studies
- Managed CMOs responsible for management of label/packaging materials, clinical labeling/packaging and distribution. Functioned as Person in-Plant to oversee labeling/packaging operations as necessary.
- Develop manufacturing plans based on estimated demand and forecasts
- Manage supply depots for clinical trials for inventory, distribution, expiry management, returns, and destruction
- Develop procedures and tools, both operational and business related, to govern day-to-day activities of the group; includes procurement, supplier qualification, document control and revisions.
- Other duties as assigned
Desired Education, Skills and Experience
- Bachelors or Master’s degree in the Life Sciences, Supply Chain Management, Industrial Engineering, or related field
- Minimum 5 years of experience in clinical supply chain management
- Demonstrated ability to work independently and with cross-functional teams, including Clinical Supply Chain, Clinical Operations, CMC, Regulatory, Quality, and Finance teams
- Proficiency in GMP/GCP processes, labeling, and import/export requirements for clinical supplies
- Previous experience with global clinical trials; US, Easter EU, Western EU, Asia/Pacific Region and an understanding of the study start up process in those regions
- Strong organizational and project management skills, including ability to multitask and organize/track information
- Previous experience with solid oral drug products a plus, and global clinical trial experience a plus
Calithera Biosciences, Inc.is an equal opportunity employer & prohibits unlawful discrimination based on
race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry,
age, disability, marital and veteran status.