|Title:||Senior Manager, Clinical Supply Chain|
The Senior Manager, Clinical Supply Chain is a key member of the clinical development team and assists in the oversight of all aspects of clinical supply planning, forecasting, capacity planning and management of study randomization vendors. This role develops and maintains clinical supply plans to include investigational products/ancillary supplies and co-meds ensuring accurate and continuous supply to assigned clinical programs while reducing risk and minimizing waste.
- Represent Clinical Supply Chain on Clinical Study Teams and provide a high service level to internal stakeholders.
- Work with Clinical Research to understand clinical demand requirements and ensures alignment with study teams on clinical supply plans and timelines.
- Oversees and manages the study CRO’s Independent (Unblinded) Study Team to ensure study integrity.
- Review of unblinded site monitoring reports to ensure follow up and resolution of identified issues.
- Ensure end of study clinical supply return/destruction of study related supplies.
- Develop and maintain clinical supply and inventory plans for assigned programs; leads cross functional clinical supply status meetings.
- Manage the relationship and oversee daily activities for clinical supply sourcing vendors.
- Manages clinical supply inventory, develops inventory reports and monitors upcoming expiry for assigned programs.
- Coordinate efforts between Project Management, Clinical Research, Technical Operations and maintains forecast and timelines for clinical supplies for assigned programs.
- Maintain routine and timely communication with Technical Operations of any changes in clinical supply forecasts or study timelines.
- Facilitate discussions and clinical review/approve decisions on label and packaging design, as needed.
- Collaborates cross-functionality with internal and external partners to determine clinical supply needs throughout the life of the study.
- Oversees the forecasting, planning, labeling/packaging and distribution of clinical supplies and/or ancillary supplies for all clinical trials.
- Responsible for the oversight of forecasting individual study initial and resupply drug needs and collaborates on supply strategies with Supply Chain colleagues.
- Responsible for assisting in the development of the overall secondary packaging and labeling strategy to support individual clinical trials (US and global, all phases) in accordance with study and program timelines.
- Recommend changes to labeling/packaging schedules for clinical drug products based on study progress and or any changes with the study plans
- Manages activities of third party vendors including CMOs and clinical supply packaging, labeling and distribution vendors, including oversight in the development of study randomization schedules (IWRS/IVRS systems).
- Develops and communicates accurate lead time requirements to clinical packaging/distribution vendors as well as internal Supply Chain.
- Systems and SOP creation as required.
- Performs other functions as assigned
- Bachelors degree in Pharmacy or a related field.
- At least 7 years of progressive experience in a clinical supply management role
- At least 5 years of experience managing multiple US and international trials, including drug projections, packaging, labeling and distribution
- Knowledge of global clinical trials and the drug development process.
- Knowledge of global pharmaceutical regulatory requirements pertaining to the procurement, manufacture, and distribution of clinical supplies (e.g. cGMP, GCP).
- Must have knowledge of US and Global clinical labeling regulations and requirements.
- Experience in vendor oversight and managing external partnerships
- Experience developing project specific budgets as well as resource planning.
- Experience with forecasting and inventory management tools is preferred
- Strong organizational, analytical, problem solving, and communication skills.
- Excellent communication and collaboration skills across levels and functions.
- Results driven with demonstrated successful outcomes.
- Must be proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet).
- Up to 20% travel may be required.