eNewsletter Signup
Miles
Km80.5

Manager, Clinical Supply Operations

Millennium: The Takeda Oncology Company

Apply
E-Mail to a Friend Add to Job Folder View All Jobs Back to Search Results Share
Location: Cambridge, MA Posted Date: 5/1/2013 Position Type: Full time Job Code: 7403BR Required Education: Bachelors Degree

Description

We Aspire to Cure Cancer! Millennium is a leading biopharmaceutical company focused on oncology that combines the agility, ideals and camaraderie of a start-up with the resources of Japans largest pharmaceutical company. The result is a creative, entrepreneurial environment where quality science and making a difference in patient lives are the priorities. Here, employees who share a drive and commitment to innovation for the benefit of oncology patients find their ideas, experience and contributions are valued and rewarded. Millennium offers great benefits, a friendly and respectful atmosphere, and a culture that promotes flexibility between work and life and encourages employees to give back to their community.

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. Position includes managing third party vendors regarding distribution of investigational product, working with CMC project leads and Clinical Operations on forecasting of supplies for clinical trials. This includes leading complex programs that may 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.

DUTIES & RESPONSIBILITIES:

Plans, establishes, manages and monitors 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. Responsible for simple and complex studies requiring project management, IVRS, medication management and the 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 planning for assigned programs. 8. Shipping and logistics: Manages the logistics activities of project(s) supply chain including initiating and managing all GMP bulk shipments across the supply chain (API, DP, FG). 9. Maintains/tracks inventory of available clinical supplies and tracks expiration dates. 10. Works within teams to identify and initiate process improvements. 11. Aids in maintaining SOPs and creating new SOPs as necessary. PREFERRED

QUALIFICATIONS:

- BS or equivalent degree in scientific or relevant discipline and 6 10 years in the pharma/biotech or CRO industry. - Project management experience preferred. - 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 good interpersonal skills.

BASIC QUALIFICATIONS:

- BS or equivalent degree in scientific or relevant discipline and 6 to 10 years in pharmaceutical, biotech or CRO industry with 5+ years in clinical supply operations. Knowledge of clinical protocol and packaging design for clinical supplies.

Requirements

Please see job description
Apply
E-Mail to a Friend Add to Job Folder



By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.

ADVERTISEMENTS