Drug Supply Manager
The Drug Supply Manager manages a small team within Drug Supply Management to support the clinical supply needs of several projects, normally within the same therapeutic area.
Responsibilities will include:
Responsibilities will include:
- Manages the drug supply component of the Drug Development Plan (including forecasting for manufacturing/procurement, packaging/labeling, and distribution) required for drug program and corresponding protocols and updating plan as required for changes to enrollment/projected treatment duration.
- Provides Clinical Supply Operations the program specific manufacturing and packaging requests, and prioritizes the associated work.
- Advises Clinical Supply Operations (CSO) and Clinical management of resource constraints and recommends strategies which will influence the ability of CSO to meet existing or anticipated demands.
- Coordinates with Operations Lead on the Full Development Team to ensure timely delivery of quality clinical supplies to support clinical programs and protocols.
- Creates close collaborations to meet key milestones in the clinical supply process including: decisions on clinical supply strategies and designs, delivery of comparators and approved documentation to support clinical supply production.
- Manages clinical supply budget.
- Sets strategic direction for drug supply outsourcing needs and nurtures relationships to make outsourcing options available.
- In collaboration with Randomization Manager, manages IVRS development activities.
- Develops and maintains effective interfaces with key customers (external and internal). Fully understands the clinical study and clinical supply processes; viewed by peers as a leader with a high level of respectability and complete knowledge of processes and strategies.
- Demonstrates leadership skills by driving for continuous improvement and encouraging and supporting collaboration across departments.
- Demonstrates a strong consistent display of team behavior by actively participating in project-related teams and is accountable for supply related component.
- Has a high level of problem solving skills and uses them to monitor key milestones in the global clinical supply process.
- Recommends and implements ways to improve the efficiency of clinical supply processes.
- Bachelor's degree in Pharmacy or related science with 5-10 years of experience in the pharmaceutical industry with a focus in clinical supplies.
- Strong understanding of the drug supply, distribution and packaging process.
- Demonstrated ability to work with and manage people/teams in a culturally diverse, complex, changing environment for the timely delivery of clinical supplies.
- Ability to effectively communicate and persuade others to accomplish clinical supply goals and objectives.
- Proven ability to develop others through leading by example.
- Ability to forecast and allocate resources to manage clinical supply programs with focus on meeting the program objectives.
- Be able to apply Research and Development operating philosophy and operate within policies and procedures.
- Must have strong problem solving skills, broad computer program literacy, including MS Word and Excel.
- Excellent knowledge of the global clinical supply and clinical study processes, of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices (GDPs) and local country drug shipment regulations.
- Project planning skills to make optimum use of resources and to meet timelines. Effective communication and knowledge of how to impact and influence people.
- Excellent interpersonal skills. Self-motivated with a proven ability to organize project activity to meet multiple project timelines.