Disclaimer
Das alfapump®-System ist derzeit weder in den Vereinigten Staaten noch in Kanada zugelassen. In den Vereinigten Staaten und Kanada befindet sich das alfapump®-System gegenwärtig in der klinischen Prüfung (POSEIDON-Studie) und wird bei erwachsenen Patienten mit refraktärem oder rezidivierendem Aszites aufgrund von Zirrhose untersucht. Weitere Informationen zur klinischen Studie POSEIDON finden Sie unter www.poseidonstudy.com.
Die DSR®-Therapie befindet sich aktuell in der Entwicklung, und es ist zu beachten, dass alle Aussagen in Bezug auf Sicherheit und Wirksamkeit auf laufenden präklinischen und klinischen Untersuchungen beruhen, die noch nicht abgeschlossen sind.
Die DSR®-Therapie ist derzeit in den Vereinigten Staaten oder Kanada nicht zur klinischen Forschung zugelassen. Es gibt keinen Zusammenhang zwischen der DSR®-Therapie und laufenden Untersuchungen mit dem alfapump®-System in Europa.
Sequana Medical NV is a commercial stage medical device company with headquarters in Ghent, Belgium and offices in Zurich, Switzerland. At Sequana Medical, we are committed to helping patients suffering from fluid overload due to liver disease, malignant ascites and heart failure. Sequana Medical’s technology is based on its proprietary alfapump® platform, a subcutaneously implanted battery-powered pump that ensures the controlled and continuous removal of fluid from the abdominal cavity into the bladder where it is eliminated through urination.
We embrace diversity and inclusion. You will have the opportunity to work with outstanding business teams and contribute to the success of the company. We strive to provide all our employees with the means to develop their skills and experiences, at every level.
Under the Direction of the Chief Medical Officer, the Director of Clinical Operations will be leading the execution of our current and future clinical trials assigned to the director, which includes the management of the clinical department in collaboration with the other management functions in the clinical department.
As a key member of the company’s management team, lead the company’s Clinical Department in collaboration with other management positions in the clinical department and be responsible for the successful execution the company’s clinical trials and clinical trial strategy assigned to the clinical director.
Design and set-up new clinical studies and manage their timely execution, including the execution of ongoing studies, up to completion, including finalization of clinical study reports and publication. You will work with the Company’s established research partners and you will help establish new research partners.
Principal duties associated with these responsibilities are summarized as follows:
If you are interested, please send your resume and motivation to careers@dev.sequanamedical.com
The manufacturing engineer’s responsibilities include introduction of new products, designing of new processes, identifying areas for improvement, maintaining high levels of manufacturing and product quality as well as ensuring cost-efficiency and conformance with regulatory standards.
Furthermore, a Manufacturing Engineer is responsible for designing, implementing and reviewing the procedures and equipment involved in the manufacturing process. Their duties include researching automation techniques, testing new systems for efficiency and planning factory layouts to optimize production.
To be successful as a manufacturing engineer you should be able to work effectively within a team and have a high level of technical expertise.
If you are interested, please send your resume and motivation to careers@dev.sequanamedical.com
Are you someone who loves to work in a fast paced, challenging environment where you will have the opportunity take on an impactful role in defining and driving purchasing initiatives? Do you thrive working in an environment where you can utilize your procurement skills to solve problems and build long-term solutions to advance procurement initiatives? Do you pride yourself on having an entrepreneurial spirit with the ability to see the big picture, deliver solutions and streamline processes? If you answered yes, we would love to discuss our Technical Buyer opportunity with you!
In this role, you will play an integral part in defining and modeling the future of procurement directly associated with Sequana Medical’s production.
If you are interested, please send your resume and motivation to careers@dev.sequanamedical.com
Acts as subject matter expert for medical device software. Creates and maintains the design history file owned by the Engineering department. Manages changes of software as part of our production environment and our product’s life-cycle management. Conducts software verification and validation according to the guidance of the Regulatory Affairs department. Manages R&D projects meeting timelines and budget. Supports other departments in technical matters. A motivated, self-organizing individual with strong analytical and communication skills.
We offer a full time (100%) contract in a very dynamic and international environment with an attractive salary package at our Zürich office.
If you are interested, please send your resume and motivation to careers@sequanamedical.com
In den USA und Kanada befindet sich der alfapump® derzeit noch in der klinischen Erprobung. Daher sind Aussagen zur Sicherheit und Wirksamkeit in diesen Gebieten nicht anwendbar.
Die DSR-Therapie befindet sich noch in der Entwicklung, und es sollte beachtet werden, dass Aussagen zur Sicherheit und Wirksamkeit aus laufenden vorklinischen und klinischen Untersuchungen stammen, die noch nicht abgeschlossen sind.
Es besteht kein Zusammenhang zwischen der DSR-Therapie und laufenden Untersuchungen mit dem alfapump®-System in Europa, den USA und Kanada.
U.S. Centers for Disease Control and Prevention, Health, United States 2016, Chartbook über Langzeit-Trends im Gesundheitswesen, Tabelle 20 (web site)
GlobalData NASH Epidemiologie-Prognose bis 2026.
Runyon et al. (2009)
European Association for the Study of the Liver. EASL klinische Richtlinien für die Behandlung von Aszites, spontane bakterielle Peritonitis und hepatorenales Syndrom bei Zirrhose. Journel of Hepatology. 2010 Bd. 53. 397-417. S. 402.
World Health Organization Internationale Agentur für Krebsforschung 2018 (http://gco.iarc.fr/today/home) (geschätzte Anzahl neuer Brust- und Ovarialfälle in 2018 (Bruttoziffer))
Ayantunde et al. (2006)
Benjamin et al. (2013)
Costanzo et al. (2007)
Costanzo et al. (2007)
Kilgore et al. (2017); Ambrosy et al. (2014)
Testani JM, Hanberg JS, Cheng S, et al. Rapid and Highly Accurate Prediction of Poor Loop Diuretic Natriuretic Response in Patients With Heart Failure. Circulation Heart failure. 2016;9(1):e002370. doi:10.1161/CIRCHEARTFAILURE.115.002370.
Ginès et al. (2004) (mit Angabe, dass refraktärer Aszites bei 5 bis 10 Prozent der Patienten mit Aszites auftritt).
Estes et al. (2018)
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