Description:
Company Information:

Breakthrough Careers!
A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.

Position Summary:

Working in the Global Investigational Supply Operations group (GISO), this position requires a pro-active individual capable of working with other functional groups to ensure clinical supplies of investigational products for multiple clinical trials are available. This individual will manage a group of 3-5 Supply Operations Project Managers who are responsible for supporting programs in Phase I thru IV. Position includes working with CMC project leads, Clinical Operations and Project Management on forecasting of supplies for clinical trials. This position may also include leading complex programs that require multinational interactions.
The candidate will participate in the development of processes, procedures and guidelines to meet both short and long term goals for clinical supplies operation, and be involved in the planning and management of activities related to clinical supplies. The candidate may be responsible for complex studies requiring project management, IVRS, medication management and/or use of advanced simulation tools.

Duties and Responsibilities:

Manage a group of Project Managers who plan, establishe, and monitor activities related to clinical supplies, to support the drug development process, in cooperation with internal and external customers and partners in compliance with multinational regulations. This individual will also be responsible for directly managing simple and complex studies requiring project management, IVRS, medication management and/or use of advanced simulation tools.

Performs functional activities of Clinical Supply Manager and performs project management activities from a clinical supplies perspective that may include but not limited to:
1. Planning, creation and maintenance of project supply plans, based on study forecasts.
2. Accountable for scheduling and delivery of CTM including label and packaging design, randomization, packaging, labeling and distribution of clinical supplies.
3. Challenges and coordinates supply chain deliverables. Ensures that key project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners.
4. Proactively drives cross-functional activities. Works with other line functions and external partners to manage complex projects.
5. Performs supply forecast simulations, contributes to the study specifications for IVRS studies, and provides medication management for highly complex studies using IVRS and simulations tools.
6. Acts as representative on CMC and clinical project teams.
7. Participates in budget, capacity and resource planning.
8. Will have managerial responsibilities.
9. Shipping and Logistics: Manage the logistics activities of project(s) supply chain including initiating and managing all GMP bulk shipments across the supply chain (API, DP, FG)
10. Maintain/track inventory of available clinical supplies and tracks expiration dates.
11. Work within team to identify and initiate process improvements.
12. Aids in maintaining SOPs and creating new SOPs as necessary.

Qualifications:

Preferred Qualifications:
- BS or equivalent degree in scientific or relevant discipline and 7-15 years in the pharma/biotech or CRO industry. Advanced degree in scientific or relevant discipline preferred.
- Line and project management experience required.
- Understanding of the development process and clinical supplies. Ability to maintain accurate records and files in accordance with GxPs and SOPs. Should be detail-oriented and possess the ability to handle multiple tasks.
- Experience in clinical trial supplies required
- Experience working in either a CRO, biotech or pharmaceutical company required
- Knowledge of clinical protocol and packaging design for supplies required
- Ability to handle multiple projects simultaneously
- Must exhibit excellent oral and written communication skills as well as go