Mgr Clinical Supply Operations in Bernards, NJ at DSI

Date Posted: 2/9/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.


Job Summary:
Responsible for ensuring clinical supplies for assigned projects are manufactured, packaged, labeled and distributed on time to support Phase 1-4 trials and required stability studies, with minimal supervision. This includes, but is not limited to assuring the availability of drug product, interpreting clinical protocols, coordinating timely product release with Regulatory and Quality functions, and managing relationships with third-party service providers. Assist in the development of department policies.

Responsibilities:
Evaluate, select, and implement contract manufacturing, packaging, and labeling operations. Negotiate work orders/proposals, oversee operations, and act as primary liaison with clinical personnel and contractor(s) on assigned projects.

Assist in the establishment of Standard Operating Procedures (SOPs) and guidelines related to production planning and scheduling, inventory management, distribution, transportation, disposition of returned/unused materials, etc.

Participate in the design of overall clinical plans and study protocols. Recommend type and method of packaging, labeling, and distribution. Design labels to meet customer needs and comply with US and foreign regulations, as appropriate.

Collaborate with clinical teams on forecasting and delivering supply assessment to the appropriate planning functions in Tokyo. Develop production plans/packaging schedules to support demand shifts resulting from enrollment changes, additional sites, etc.

Recommend matching placebo and comparator drug sources. Develop appropriate blinding strategies and coordinate team efforts for analytical method development, stability studies and regulatory CMC filing (domestic and international).

Identify emerging trends, technologies, and best practices and implement as appropriate.


Qualifications:
Education:

BS/BA required. Degree in pharmacy or related field preferred. MS or PharmD is highly beneficial.

Experience:
Minimum 5 years of related experience, including Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination. Demonstrated experience in working on Oncology, Cardiovascular and/or other therapeutic area trials including inventory management, forecasting drug supply needs globally, IXRS experience, managing vendors and contributing to budget control. The day to day requirements of the position are considered those of an individual contributor.


Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.