Head of Clinical Affairs

vor 3 Wochen


Zurich, Schweiz Batterman Consulting Basel AG Vollzeit

**magnetic blood purification****:
**Unser Kunde**

hemotune AG ist ein Schweizer Medizintechnik-Start-up-Unternehmen, das aus der ETH Zürich hervorgegangen ist. Das Ziel ist die Entwicklung eines lebensrettenden, bahnbrechenden Medizinprodukts für die gezielte Blutreinigung.

Das Unternehmen mit Standort in Zürich befindet sich zurzeit in der präklinischen Entwicklungsphase. Zur Unterstützung des Teams suchen wir eine/n:
**Head of Clinical Affairs (w/m/d) 80-100%****:
**Ihr Verantwortungsbereich**
- Verantwortlich für alle klinischen Prüfungen sowie deren Vorbereitung, Planung, Umsetzung und Einreichung nach den Regularien (ISO 14155, ICH-GCP)
- Verfassen von Dokumenten für klinische Prüfungen (z. B. CIP, CRF, Einverständniserklärung, Patienteninformationen) gemäss ISO 14155, ICH-GCP und geltenden Normen
- Wöchentliche Berichterstattung an den CEO
- Durchführen von internen und externen Audits
- Mitwirkung bei der strategischen Geschäftsentwicklung
- Unterstützung bei der Überprüfung von Publikationsentwürfen
- Verantwortung für die Budget
- und Zeitplanung für die gesamte klinische Strategie
- Mitarbeit im Projektteams für die Weiterentwicklungen der Produktdefinition bis zum Markt Launch
- Vorbereitung von wissenschaftlichen Veröffentlichungen der klinischen Daten
- Durchführung von klinischen Bewertungen
- Verantwortlich für die externe Kommunikation mit den Stakeholdern

**Ihr Profil**
- Erfolgreich abgeschlossenes naturwissenschaftliches Studium in einem klinischen Bereich oder vergleichbar
- Langjährige Erfahrung im klinischen Projektmanagement in der klinischen Forschungsabteilung von Medizinprodukten/Pharmaunternehmen/CRO
- Profunde Berufserfahrung im Bereich klinische Bewertung von Medizinprodukten (Klasse II - III)
- Umfangreiche Kenntnisse den einschlägigen europäischen und internationalen Regularien (GPC / ISO 14155)
- Sehr gute Englisch
- und Deutschkenntnisse in Wort und Schrift
- Analytische Fähigkeiten und Kreativität sowie Kommunikationsstärke und Organisationstalent in einem internationalen Umfeld

**Ihre Vorteile**
- Mitwirkung in der Markteinführung
- Dynamisches Arbeitsumfeld in einem hoch motivierten Start-up-Team, mit flachen Hierarchien und viel Raum für Selbstverwirklichung und Umsetzung Ihrer Ideen
- Einen spannenden und modernen Arbeitsplatz im Bio-Technopark Schlieren
- Flexible Arbeitszeiten und mobiles Arbeiten



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