Description

***Debiopharm*** *is privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique -development only- business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow.*

For our Pharmaceutical Development organization based at our Headquarters in Lausanne, we are looking for a

**Global Clinical Trial Supply Manager**

In this international team in the **Global Clinical Trial Supply Manager** role, you will work on a diverse array of molecules-including **small and large molecules, radiopharmaceuticals, and ADC compounds**-offering unparalleled breadth in the function. You will manage the delivery of products from **Investigational Medicinal Products** (IMP) including Comparators / Standards of Care according to the study protocol and the project plan in terms of quantity, timelines and ensuring high quality.

**Your responsibilities will be but not limited to:**

* Based on the trial design, you evaluate the feasibility and build a proposal for the clinical trials supply, considering packaging design, quality and regulatory compliance and supply chain
* You define the IMP needs and supply strategy with the CMC Project Leader and the Clinical Trial Leader (CTL)
* You are responsible for the clinical supply chain, managing the Contract Manufacturing Organization (CMO) performing the operational activities from contract award, packaging design to on-site delivery to the clinical site, return, reconciliation and destruction
* You set-up and co-ordinate the packaging, labelling, storage and management of IMP with the internal (data management, CTL,...) and external stakeholders (Contract Research Organization(CRO), CMO, Interactive Response Technology (IRT) vendors)
* You coordinate the sponsor and Qualified Person release of IMP in collaboration with both internal and external (CMO) Quality Management, as well as Regulatory Affairs
* You ensure study related key CMC documents are accurate and available in the electronic Trial Master File (e-TMF) as per Good Clinical Practices guidelines

* At least 4 year of experience in Global Clinical Trial Supplies management within the Pharmaceutical industry **for phase I to phase III international clinical studies** (double-blind, comparator and standard of care sourcing)

* A combined experience of clinical trial supplies with both Sponsor and CRO/CDMO is a plus
* Broad understanding and experience in setting up (specification definition) of the main tools related to IMP management (simulation tools, IRT/Interactive Web Response System,-)
* 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

* 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

 

*The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.*

*Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.*

*Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.*