Clinical Trial Supply Manager
Debiopharm Group, Switzerland
Job Description
Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
Here: https://apply.workable.com/debiopharm-group-sa/
For our Pharmaceutical Development Department based in Lausanne we are looking for a:
Clinical Trial Supply Manager
In this role, you will manage the delivery of Investigational Medicinal Products (IMP) including Comparators / Standards of Care according to the study protocol and the project plan in terms of quantity, quality and timelines.
Your responsibilities will be but not limited to:
- Based on protocol outlines, you evaluate the feasibility and build a proposal for the supply of clinical trials in terms of packaging design, quality and regulatory compliance and supply chain
- You manage the Contract Manufacturing Organization (CMO) performing the operational activities from packaging design to on site delivery, return, reconciliation and destruction
- You collaborate to the IMP needs estimate and define a supply strategy with the CMC Project Leader and the Clinical Trial Manager (CTM)
- You set-up the packaging, labelling, storage and management of IMP with the internal (data management, CTM,...) 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
Requirements
- At least 4year of experience in 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 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 skills, ability to work cross-functionally
- English fluent, good knowledge of French an asset
Benefits
Debiopharm can offer you
- An international and highly dynamic environment, with a long term vision.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
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.