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Clinical Supply Project Manager

2 months ago

Trenton, New Jersey, United States Daiichi Sankyo Full time

Join a Legacy of Innovation - 110 Years and Counting

Daiichi Sankyo Group is committed to the development and provision of pioneering pharmaceutical solutions aimed at enhancing healthcare standards and addressing diverse, unmet medical requirements worldwide by utilizing our exceptional scientific and technological capabilities. With over 120 years of scientific proficiency and a presence in more than 20 nations, Daiichi Sankyo and its 16,000 global employees leverage a rich history of innovation and a strong pipeline of promising new therapies to assist individuals. In addition to a robust portfolio of medications for cardiovascular conditions, under the Group's 2025 Vision to evolve into a Global Pharma Innovator with a Competitive Edge in Oncology, Daiichi Sankyo primarily focuses on delivering novel treatments in oncology, alongside other research domains centered on rare diseases and immune disorders.

Position Overview

This role is essential for facilitating the timely delivery of clinical supplies across the DSI portfolio. The incumbent will play a pivotal role in assisting CSO Project Management Leads by formulating and revising Study Supply Plans, overseeing various workflows with key service providers, and collaborating with internal departments to advance clinical supply initiatives. While this description aims to capture the core responsibilities of the position, it does not imply that these are the only tasks required, nor is it an exhaustive list of the skills and competencies necessary for the role. The absence of specific duty statements does not exclude them from the position if the work is similar, related, or an essential function of the role.

Key Responsibilities

  • Formulates and revises Study Supply Plans in close collaboration with the CSO Project Management Lead.
  • Oversees the Clinical Label Development process, which encompasses the creation of master label text, translations, and label proofs.
  • Manages the review and approval process for packaging Batch Records in conjunction with Quality Assurance and other CSO personnel.
  • Collaborates closely with Quality Assurance to secure temperature excursion dispositions to update affected inventory in IRT and related systems.
  • Coordinates the authorized destruction of investigational products with approved vendors and secures necessary documentation.
  • Supports Vendor Management during Person in Plant (PIP) activities when packaging operations for DSI are underway. Assists in investigational product distribution activities at the vendor, including generating drug orders, reviewing shipping documentation, and obtaining shipping approvals.
  • Aids in the creation of Standard Operating Procedures (SOPs) and work instructions specific to CSO Supply Planning as needed.
  • Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents.
  • Assists the CSO Project Management Lead in executing additional operational and logistical responsibilities as discussed and agreed upon by management.

Qualifications

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

  • Education: Bachelor's Degree required; extensive relevant experience may be considered in lieu of an advanced degree. PharmD or related field preferred; Master's Degree preferred.
  • Experience: 7 or more years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development preferred. Oncology experience preferred. Experience in creating Supply Planning tools preferred.

Travel Requirements

Ability to travel up to 10%. Overnight/single-day travel may be required to visit outsourcing vendors occasionally.

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.