Project Lead, Program Management, CSP&O Clinical Supply Planning and Operations

4 weeks ago

Bernards, United States Daiichi Sankyo, Inc. Full time

Join a Legacy of Innovation 110 Years and Counting

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

NOTE:  This Project Lead Role is an Individual Contributor and sits at the Manager Grade level.

This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role as CSO (Clinical Supply Planning and Operations) Project Lead is primarily responsible for developing and updating Study Supply Plans, managing various work streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.

Responsibilities

  • Develops and updates Study Supply Plans in close communication with CSO project Management Lead
  • Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs.
  • Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.
  • Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.
  • Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.
  • Vendor Management –supports Person in Plant (PIP) activities when packaging operations for DSI are in-process. Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship
  • Assists in the creation of SOP’s and work instructions specific to CSO Supply Planning as requested.
  • Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents
  • Supports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and agreed to by management

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

  • Bachelor's Degree required
  • Extensive relevant experience will be considered in lieu of an advanced degree. preferred
  • PharmD or related field preferred
  • Master's Degree preferred

Experience Qualifications

  • 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. preferred
  • Oncology experience preferred
  • Creation of Supply Planning tools preferred

Travel

Ability to travel up to 10%. Overnight / single-day travel will be required to go to outsourcing vendors from time to time infrequently.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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.

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