Global Clinical Trial Supply Chain Manager

vor 4 Wochen

Lausanne, Waadt, Schweiz Debiopharm Vollzeit

Debiopharm is a Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases to improve patient outcomes and quality of life. Our unique business model enables us to develop innovative therapies and act as a bridge between disruptive discovery products and patient access in international markets.

At Debiopharm, you will be part of a team that is at the forefront of the fight against cancer and infectious diseases through innovative medicines for patients. We are seeking a Global Clinical Trial Supply Chain Manager for our Pharmaceutical Development organization based at our Headquarters in Lausanne.

In this role, you will work on a diverse array of molecules, including small and large molecules, radiopharmaceuticals, and ADC compounds. You will manage the delivery of products from Investigational Medicinal Products (IMP) according to the study protocol and project plan in terms of quantity, timelines, and ensuring high quality.

Your responsibilities will include:

  • Evaluating the feasibility of clinical trials supply and building a proposal considering packaging design, quality, and regulatory compliance and supply chain.
  • Defining the IMP needs and supply strategy with the CMC Project Leader and the Clinical Trial Leader (CTL).
  • Managing the clinical supply chain, including Contract Manufacturing Organization (CMO) activities from contract award to on-site delivery to the clinical site, return, reconciliation, and destruction.
  • Setting up and coordinating the packaging, labeling, storage, and management of IMP with internal and external stakeholders.
  • Coordinating the sponsor and Qualified Person release of IMP in collaboration with internal and external Quality Management and Regulatory Affairs.
  • Ensuring 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.
  • A combined experience of clinical trial supplies with both Sponsor and CRO/CDMO is a plus.
  • Broad understanding and experience in setting up 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.

Benefits

  • 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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