Associate Director, Clinical CMO ManagementApply Now Email Me Job ID R0006529 Date posted 01/15/2019 Location:Fujisawa, Japan
Please note that this job requires native level Japanese language command not only in speaking, but also in business writing and reading.
Takeda is unwavering in our commitment to patients. With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives - we’re looking for like-minded professionals to join us.
Today, we are the number one pharmaceutical company in Japan and a global industry leader, with approximately 30,000 employees around the world. We are united by our four priorities (patient, trust, reputation and business) and Takeda-ism (Integrity, Fairness, Honesty and Perseverance) , and strive towards better health and a brighter future for people worldwide.
Provides project management and leadership to support clinical CMO manufacturing activities. Recognized expert in managing the logistical and operational aspects of assigned projects and/or processes. The position requires in-depth interactions with scientists and quality specialists from various departments and external vendors.
- Lead the project management for outsourced global projects with multiple work streams (drug substance, drug product, logistics, etc.) and integrate implications for any external operations opportunities.
- Accountable for assessment and evaluation of CMO and vendor capabilities critical for successful delivery of Takeda’s clinical development portfolio, in partnership with PS Functional SMEs.
- Act as an operational liaison between Clinical Supply Chain and stakeholders, Takeda partners, and contract manufacturing organizations. Effectively engage with key stakeholders (internal and external) to ensure timely implementation of project objectives. Identify interdependencies and connections between departments and ensure integrated end to end visibility and alignment.
- Provide a single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO governance structure.
- Demonstrate an understanding of company priorities, objectives and project timelines. Define and manage critical path, proactively identify and escalate issues and help resolve them.
- Develop and manage mutually beneficial, long-term business relationships with CMOs.
- Demonstrate strategic thought and resource planning to support multi-geographic programs and personnel.
- Identify and communicate opportunities for change; plans for team to meet new challenges.
- Lead and support Clinical Supply Chain business initiatives and facilitate their implementation with appropriate stakeholders
EDUCATION, EXPERIENCE AND SKILLS:
- BS and 10+ years experience or advanced degree and 8+ years of experience
- Must have exceptional working knowledge of CMC operations relating to research and development and investigational drug manufacturing. Must have direct management experience with external contract manufacturing organizations.
- Demonstrated excellence in project management and effectively managing multiple projects/priorities.
- Experience implementing systems and processes for support of cross-functional activities.
- Must have strong PC experience along with expert in MS Office suite applications.
- Able to troubleshoot critical issues or problems and resolve routine issues using appropriate information.
- Ability to work well in a cross functional team environment, build consensus and drive resolution of issues while maintaining positive working relationships across functions.
- Exceptional oral and written communications skills with the capacity to present effectively to a diverse range of audiences.
- Exercises exceptional time management skills and is able to successfully manage multiple tasks simultaneously.
- Demonstrate a high degree of self-awareness, self-motivation, initiative, and attention to detail.
- Office work
- Computer use
- Airline travel
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 5-10% travel.
WHAT TAKEDA CAN OFFER YOU:
- Allowances: Commutation, Housing, Overtime Work etc.
- Working Hours: Headquaters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, Research Site (Kanagawa) 9:00-17:45
- Holidays: Saturdays, Sundays, National Holidays, May Day,
- Year-End Holidays etc. (approx. 123 days in a year)
- Paid Leaves: Annual Paid Leave, Special Paid Leave, Refresh Leave,
- Maternity Leave, Childcare Leave, Family Nursing Leave, Philanthropy Leave.
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