P2420 - Global Clinical Trial Supply Manager

vor 1 Tag

Lausanne, Schweiz TN Switzerland Vollzeit
P2420 - Global Clinical Trial Supply Manager, LausanneClient:

Debiopharm

Location:

Lausanne

Job Category:

Other

Job Reference:

c89d3d139ce5

Job Views:

9

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life. At Debiopharm, you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients.

For our Pharmaceutical Development organization based at our Headquarters in Lausanne, we are looking for a Global Clinical Trial Supply Manager.

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

Your responsibilities will include:

  • Evaluating the feasibility and building a proposal for clinical trials supply based on trial design, considering packaging design, quality, regulatory compliance, and supply chain.
  • Defining the IMP needs and supply strategy with the CMC Project Leader and Clinical Trial Leader (CTL).
  • Managing the clinical supply chain, overseeing the Contract Manufacturing Organization (CMO) from contract award to on-site delivery, return, reconciliation, and destruction.
  • 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.
  • 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.
  • Understanding of regulatory and Good Manufacturing Practices requirements for IMP supply.
  • Project management skills with expertise in outsourcing.
  • Excellent communication and problem-solving skills.
  • Team player looking to join a collaborative, supportive, and friendly team.
  • Fluency in English; good knowledge of French is an asset.

Please note that if you are NOT a passport holder of the country for the vacancy, you might need a work permit. Bank or payment details should not be provided when applying for a job.

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