Clinical Supply Planning and Operations Project Lead

4 weeks ago


San Francisco, California, United States Daiichi Sankyo, Inc. Full time

Transforming Clinical Supply Planning

Daiichi Sankyo Group is dedicated to delivering innovative pharmaceutical therapies to improve healthcare standards globally. As a Clinical Supply Planning and Operations Project Lead, you will play a pivotal role in enabling the timely delivery of clinical supplies across our portfolio.

Key Responsibilities:

  • Develop and update Study Supply Plans in collaboration with CSO project management.
  • Lead the Clinical Label Development process, including master label text creation, translations, and label proofs.
  • Manage the packaging Batch Record review and approval process with Quality Assurance and CSO personnel.
  • Work closely with Quality Assurance to obtain temperature excursion disposition and update impacted inventory in IRT and other systems.
  • Coordinate authorized destruction of investigational products with approved vendors and obtain required documentation.
  • Support Person in Plant (PIP) activities and investigational product distribution activities at the vendor.
  • Assist in creating SOPs and work instructions specific to CSO Supply Planning as requested.
  • Update relevant Trial Master Files (TMF) with CSO-related documents.
  • Support the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and agreed to by management.

Requirements:

  • Bachelor's Degree required; extensive relevant experience will be considered in lieu of an advanced degree.
  • 7 or more years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development.
  • Oncology experience preferred.
  • Creation of Supply Planning tools preferred.

Travel: Ability to travel up to 10% for outsourcing vendor visits.

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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