BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSenior
Mainz, München
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BIBioNTech SE
Director Clinical Operations(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Developing portfolio documents and process improvements for novel drug trials. Project management and regulatory submission experience in drug development required. International project scope.
Anforderungen
- Natural/life sciences or medical background
- Knowledge of legislation and ICH-GCP guidelines
- Experience in project management and submissions
- Refined colloquial and correspondence skills
- Proficiency in standard office software
- Readiness to take responsibility
- Team leadership and motivation skills
- Problem recognition and solution skills
- Excellent organizational and communicative skills
- Independent and proactive working style
Aufgaben
- Lead and supervise clinical trial teams
- Develop portfolio documents and oversight plans
- Create process developments and trial RACIs
- Draft and update standard operating procedures
- Ensure adherence to ICH-GCP and regulatory guidelines
- Conduct training on relevant clinical procedures
- Act as the escalation point for project challenges
- Manage external vendors and sponsor department relations
- Line manage clinical trial managers and associate directors
- Plan team resources with the Senior Director
- Govern and oversee CROs and external vendors
- Direct vendor selection and strategic sourcing approaches
- Monitor project timelines and program deliverables
- Identify and address future program needs
- Organize and facilitate regular team meetings
- Identify high-performance members and foster team development
- Support the QA team during audits and inspections
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- ICH-GCP
- Word
- Excel
- PowerPoint
- MS Project
Benefits
Attraktive Vergütung
- Competitive remuneration packages
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- BioNTech SE
Senior Director, Global Medical Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Executive Director Manufacturing Network QA(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Vollzeitnur vor OrtSeniorMainz
BIBioNTech SE
Director Clinical Operations(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Developing portfolio documents and process improvements for novel drug trials. Project management and regulatory submission experience in drug development required. International project scope.
Anforderungen
- Natural/life sciences or medical background
- Knowledge of legislation and ICH-GCP guidelines
- Experience in project management and submissions
- Refined colloquial and correspondence skills
- Proficiency in standard office software
- Readiness to take responsibility
- Team leadership and motivation skills
- Problem recognition and solution skills
- Excellent organizational and communicative skills
- Independent and proactive working style
Aufgaben
- Lead and supervise clinical trial teams
- Develop portfolio documents and oversight plans
- Create process developments and trial RACIs
- Draft and update standard operating procedures
- Ensure adherence to ICH-GCP and regulatory guidelines
- Conduct training on relevant clinical procedures
- Act as the escalation point for project challenges
- Manage external vendors and sponsor department relations
- Line manage clinical trial managers and associate directors
- Plan team resources with the Senior Director
- Govern and oversee CROs and external vendors
- Direct vendor selection and strategic sourcing approaches
- Monitor project timelines and program deliverables
- Identify and address future program needs
- Organize and facilitate regular team meetings
- Identify high-performance members and foster team development
- Support the QA team during audits and inspections
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- ICH-GCP
- Word
- Excel
- PowerPoint
- MS Project
Benefits
Attraktive Vergütung
- Competitive remuneration packages
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
BioNTech SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Noch nicht perfekt?
- BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - BioNTech SE
Senior Director, Global Medical Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Executive Director Manufacturing Network QA(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Vollzeitnur vor OrtSeniorMainz