What are the responsibilities and job description for the Manager, Global Clinical Trial Drug Supply position at ThisWay?
Our partner is looking for a Manager, Global Clinical Trial Drug Supply for a full-time position based in New York, NY. The Manager will be responsible for executing optimal clinical trial supply strategies and ensuring continuity of drug supply combination therapy to patients.
This is a full time, exempt role reporting to the Director, US Operations and is based either in our Portsmouth, NH office or remotely with the ability to travel to Portsmouth, NH monthly. Also, travel (domestic and international) to coordinate and collaborate with clinical teams and drug manufacturers required, as needed.
Responsibilities:
- Own all aspects of clinical drug supply management with third-party vendors, from receipt at the initial depot to destruction.
- Manage contracting and collaboration with internal leadership teams to ensure business continuity of labeling, packaging, transfer, storage, and transportation logistics of final drug products.
- Collaborate with third-party vendors for clinical drug demand forecasting and planning.
- Update drug demand based on study changes and align with Clinical Operations and external manufacturing teams.
- Identify risks related to pharmaceutical ordering, labeling, packaging, storage, and customs.
- Collaborate with Clinical Operations and Planning Team to monitor study activity and address any modifications to drug supply.
- Develop and maintain optimal resupply strategies with third-party vendors for proactive planning and compliance.
- Manage global customs and monitor inbound and outbound shipments for drug compliance and timely deliveries/reordering.
- Carry out project management assignments.
- Travel required 25-40% (domestic and international).
*Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
- 5 years of experience in clinical trial drug supply management within the bio/pharmaceutical industry.
- Bachelor's Degree in Life Sciences, Pharmacy, Engineering, or a related field.
- Understanding of global customs regulations and procedures.
- Knowledge of global pharmaceutical rules and regulations.
- Ability to prepare global documentation for vendors and customs.
- Familiarity with FDA regulations for pharmaceutical and DME applications.
- Experience in clinical packaging, labeling, drug depot warehousing, and transportation/distribution.
- Proficiency in MS Excel, Access, and other data analysis tools.
