BioNTech SE
Senior Director, Safety Sciences Lead(m/w/x)
Vollzeitnur vor OrtSenior
Mainz, München
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BIBioNTech SE
Director Safety Physician(m/w/x)
Mainz, München
ab USD 168.100 - 268.700 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Medical safety expertise for oncology drug development, including clinical trial protocol contributions and investigator training. MD/PhD and extensive drug safety experience required. Annual bonus and equity.
Anforderungen
- Medical Degree or equivalent
- MD/PhD and/or certified training in medical discipline (plus)
- Extensive drug safety/pharmacovigilance experience
- Experience in innovative drug development
- Experience with BLA/MAA submissions
- Advisory committee experience
- Experience in immuno-oncology/inflammation therapeutic areas (preferred)
- Exposure to regulatory agencies on development strategies
- Direct experience with regulatory agencies on development strategies
- Experience with innovative oncology product development strategies
- Experience with US regulatory agencies (particularly)
- Demonstrable results in matrix organization
- Demonstrable results in multidisciplinary team
- Experience implementing GCP standards in clinical trials
- Experience with safety reporting compliance
Aufgaben
- Support oncology therapeutic area with medical safety expertise
- Collaborate with Safety Scientists to ensure patient safety
- Contribute to clinical trial protocols
- Train investigators on safety procedures
- Assess safety data, including adverse events and serious adverse events
- Determine necessary follow-up actions for safety concerns
- Conduct safety signal detection and evaluation
- Ensure compliance with Good Clinical Practice (GCP) and regulatory reporting
- Contribute to Development Safety Update Reports (DSURs)
- Update reference safety information
- Revise Investigator Brochures
- Prepare Clinical Trial Reports
- Oversee safety monitoring and signal management
- Manage benefit-risk of assigned products throughout the product life cycle
- Identify and lead escalation of safety inquiries and concerns
- Formulate and drive optimal safety strategy for oncology programs
- Present and interact with Regulatory Authorities on safety matters
- Oversee quality content of safety contributions to clinical and regulatory documents
- Participate in due diligence for BioNTech’s Licensing/Acquisition initiatives
- Represent MSPv in Alliance management projects
- Negotiate safety data exchange agreements
- Serve on joint oversight committees with development partners
- Ensure activities comply with applicable laws and regulations
- Train and mentor Safety Physicians and Safety Scientists
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Boni & Prämien
- Annual bonus
Attraktive Vergütung
- Equity
- Competitive remuneration packages
Mitarbeiterrabatte
- Variety of benefits
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.
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BIBioNTech SE
Director Safety Physician(m/w/x)
Mainz, München
ab USD 168.100 - 268.700 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Medical safety expertise for oncology drug development, including clinical trial protocol contributions and investigator training. MD/PhD and extensive drug safety experience required. Annual bonus and equity.
Anforderungen
- Medical Degree or equivalent
- MD/PhD and/or certified training in medical discipline (plus)
- Extensive drug safety/pharmacovigilance experience
- Experience in innovative drug development
- Experience with BLA/MAA submissions
- Advisory committee experience
- Experience in immuno-oncology/inflammation therapeutic areas (preferred)
- Exposure to regulatory agencies on development strategies
- Direct experience with regulatory agencies on development strategies
- Experience with innovative oncology product development strategies
- Experience with US regulatory agencies (particularly)
- Demonstrable results in matrix organization
- Demonstrable results in multidisciplinary team
- Experience implementing GCP standards in clinical trials
- Experience with safety reporting compliance
Aufgaben
- Support oncology therapeutic area with medical safety expertise
- Collaborate with Safety Scientists to ensure patient safety
- Contribute to clinical trial protocols
- Train investigators on safety procedures
- Assess safety data, including adverse events and serious adverse events
- Determine necessary follow-up actions for safety concerns
- Conduct safety signal detection and evaluation
- Ensure compliance with Good Clinical Practice (GCP) and regulatory reporting
- Contribute to Development Safety Update Reports (DSURs)
- Update reference safety information
- Revise Investigator Brochures
- Prepare Clinical Trial Reports
- Oversee safety monitoring and signal management
- Manage benefit-risk of assigned products throughout the product life cycle
- Identify and lead escalation of safety inquiries and concerns
- Formulate and drive optimal safety strategy for oncology programs
- Present and interact with Regulatory Authorities on safety matters
- Oversee quality content of safety contributions to clinical and regulatory documents
- Participate in due diligence for BioNTech’s Licensing/Acquisition initiatives
- Represent MSPv in Alliance management projects
- Negotiate safety data exchange agreements
- Serve on joint oversight committees with development partners
- Ensure activities comply with applicable laws and regulations
- Train and mentor Safety Physicians and Safety Scientists
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Boni & Prämien
- Annual bonus
Attraktive Vergütung
- Equity
- Competitive remuneration packages
Mitarbeiterrabatte
- Variety of benefits
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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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
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