Global Clinical Trial Supply Manager

Vor 5 Tagen

Lausanne, Waadt, Schweiz Debiopharm Vollzeit

About Debiopharm

Debiopharm International SA is a privately-owned Swiss biopharmaceutical company dedicated to research and development in oncology and infectious diseases. Our mission is to improve patient outcomes and quality of life through innovative therapies.

Job Summary

We are seeking a highly skilled Global Clinical Trial Supply Manager to join our Pharmaceutical Development organization at our Headquarters in Lausanne. As a key member of our international team, you will be responsible for managing the delivery of Investigational Medicinal Products (IMPs) from contract manufacturers to clinical sites worldwide.

Key Responsibilities

  • Evaluate the feasibility of clinical trials supply and develop proposals for packaging design, quality, and regulatory compliance.
  • Define IMP needs and supply strategy with the CMC Project Leader and Clinical Trial Leader.
  • Manage the clinical supply chain, including contract manufacturing organizations (CMOs), packaging design, labeling, storage, and management of IMPs.
  • Coordinate the sponsor and Qualified Person release of IMPs with internal and external stakeholders.
  • Ensure study-related key CMC documents are accurate and available in the electronic Trial Master File (e-TMF) as per Good Clinical Practices guidelines.

Requirements

  • At least 4 years of experience in Global Clinical Trial Supplies management within the Pharmaceutical industry for phase I to phase III international clinical studies.
  • Broad understanding and experience in setting up specification definition of main tools related to IMP management.
  • Broad understanding of regulatory and Good Manufacturing Practices requirements for IMP supply.
  • First experience of project management skills, with expertise of outsourcing.
  • Excellent communication and problem-solving skills.
  • Team Player - looking to join a collaborative, supportive, and friendly team.
  • English fluent, good knowledge of French an asset.

What We Offer

  • International, highly dynamic environment with a long-term vision.
  • Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry.
  • Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry.
  • Participation in a company where innovation, people, and entrepreneurship are the fundamental keys to success.
  • Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities.

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