Clinical Supply Chain Operations Senior Manager

2 weeks ago

Cheyenne, Wyoming, United States Sumitomo Pharma Full time
Company Overview

Sumitomo Pharma Co., Ltd. is a leading global pharmaceutical organization headquartered in Japan, with significant operations across the U.S., Canada, and Europe. Our focus is on meeting patient needs in various therapeutic areas including oncology, urology, women's health, rare diseases, psychiatry & neurology, and innovative cell & gene therapies.

Position Summary

We are in search of a highly skilled and motivated individual to fill the role of Senior Manager, Clinical Supply Chain. This pivotal position involves overseeing the planning, management, and distribution of clinical supplies across multiple clinical programs.

Key Responsibilities
  • Lead comprehensive Clinical Supply Chain operations including planning, packaging, labeling, distribution, and inventory management for assigned clinical programs.
  • Develop and maintain accurate supply forecasts and timelines in collaboration with Clinical and CMC teams.
  • Oversee inventory levels at depots and clinical sites, ensuring seamless coordination from manufacturers to clinical locations.
  • Review and design label text to ensure compliance with both U.S. and international regulations.
  • Ensure optimal management of investigational products in accordance with clinical protocols and regulatory standards.
  • Collaborate closely with various departments such as Clinical Operations, CMC, Regulatory Affairs, and Quality Assurance to ensure clinical program advancement.
  • Coordinate with Commercial Supply Chain for the utilization of commercial products in clinical trials.
  • Manage logistics and resolve issues related to shipment delays and temperature excursions.
  • Develop and oversee clinical trial Interactive Response Technology (IRT) systems, including specifications and User Acceptance Testing (UAT).
  • Participate in initiatives aimed at process improvements within the clinical supply chain and develop necessary SOPs.
  • Manage clinical trial contracts and budgets, ensuring effective oversight of clinical supply vendors.
  • Represent the Clinical Supply Chain function in clinical trial meetings, effectively communicating plans and timelines.
  • Mentor and develop team members as required.
Qualifications

A Bachelor’s degree in life sciences or business is required, with a Master’s degree preferred. Candidates should possess a minimum of 8-12 years of relevant experience in the life sciences industry, including Project Management and Clinical Supply Management, with at least 3 years specifically in Clinical Supplies Management.

Proficiency in Microsoft Excel, PowerPoint, and Project software is essential. APICS certification (CPIM, CLTD, CSCP) is preferred.

Mental/Physical Requirements

This role requires the ability to thrive in a fast-paced environment while managing multiple priorities. Strong judgment, initiative, and excellent communication skills are essential. Candidates should be comfortable using a personal computer for extended periods.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer, committed to fostering a diverse workforce.

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