Clinical Supply Chain Operations Manager

2 weeks ago


Concord, New Hampshire, United States Sumitomo Pharma Full time

Position Overview:
We are seeking a proactive and skilled individual to take on the role of Clinical Supply Chain Operations Manager at Sumitomo Pharma. This position plays a critical role in overseeing the comprehensive management of clinical supply chain processes.

Key Responsibilities:
As the Clinical Supply Chain Operations Manager, you will be responsible for:

  • Leading and coordinating all aspects of the clinical supply chain, including planning, packaging, labeling, distribution, and inventory management for various clinical programs.
  • Developing accurate supply forecasts and timelines in collaboration with Clinical and CMC teams.
  • Managing inventory levels effectively at depots and clinical sites, ensuring seamless coordination from manufacturers to clinical locations.
  • Reviewing and designing label text to ensure compliance with regulatory standards.
  • Ensuring adherence to clinical protocols and regulatory requirements, including cGMP, GCP, ICH, and FDA guidelines.
  • Collaborating with cross-functional teams such as Clinical Operations, Regulatory Affairs, and Quality Assurance to ensure the readiness of clinical supplies.
  • Addressing logistical challenges, including shipment delays and temperature excursions, while working closely with the Trade Compliance & Logistics team.
  • Overseeing the development and management of clinical trial IRT systems, including user acceptance testing and daily operations.
  • Participating in process improvement initiatives and developing standard operating procedures for clinical supply chain activities.
  • Managing contracts and budgets related to clinical supply vendors.
  • Mentoring and developing team members to enhance their skills and performance.

Qualifications:
Applicants should possess a BS/BA degree in life sciences or business (Master's preferred) and have a minimum of 8-12 years of relevant experience in the life sciences industry, particularly in Project Management, Pharmaceutical Development, or Clinical Supply Management. Proficiency in Microsoft Excel, PowerPoint, and Project software is required, along with APICS certification preferred.

Compliance and Ethics:
It is essential to maintain compliance with all applicable regulatory and operational standards, ensuring that all activities are conducted with the highest ethical practices.

Work Environment:
This role operates in a fast-paced environment that requires the ability to manage multiple priorities effectively. Strong written and verbal communication skills are necessary, along with the capability to work independently and exercise sound judgment.


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