Dein persönlicher KI-Karriere-Agent
Clinical Lead, Early Clinical and Experimental Therapeutics(m/w/x)
Designing early development plans and First-In-Human studies for novel therapeutics. Basic science, translational medicine, or clinical research experience required. Employee benefit programs.
Anforderungen
- Experience in basic science, translational medicine, or clinical research
- Very good communication skills (verbal and written)
- Capability to challenge decisions and status quo with risk-management approach
- Ability to work within a matrix organization
- International/intercultural working skills
- Open-mindedness to apply new digital or AI-driven solutions
- Advanced degree: M.D. or M.D./Ph.D with at least 1-5 years of research experience
- Broad immunology, neurology, or ophthalmology knowledge base
- Knowledge and mindset in translational research
- Ability to acquire and apply new technical skills
- Postgraduate residency training; laboratory research in industry or academia is a plus
- Experience in the conduct of late phase clinical trials
Aufgaben
- Design early development plans and ECET plans for clinical development
- Integrate plans into overall development strategy with Therapeutic Area teams
- Create safe, rapid, and informative First-In-Human studies
- Conduct natural history, experimental model validation, and mechanistic trials
- Supervise study execution and ensure close medical monitoring
- Review and interpret study results
- Author ECET-related clinical documentation
- Interact with managers from various disciplines
- Serve as an expert and internal consultant
- Participate in dose selection for First-In-Human studies
- Drive Go/No Go decisions
- Ensure adequate follow-up of studies and project timelines
- Present data at internal and external meetings
- Maintain Clinical Trial standards
- Ensure high-quality documents
- Manage aggressive timelines through cross-functional planning
- Make front-line decisions on protocol design, execution, and safety
- Coordinate clinical team for study setup and follow-up
- Review and approve study documentation
- Ensure proper documentation for Ethics Committees and Health Authorities
- Prepare and review interim investigator reports
- Lead Dose Escalation Meetings and document decisions
- Review Adverse Event reports
- Participate in data review and validation meetings
- Prepare and distribute Key Results Memos
- Prepare and review Clinical Study Reports
Berufserfahrung
- 1 - 5 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Englisch – verhandlungssicher
Benefits
Mitarbeiterrabatte
- Employee benefit programs
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Clinical Lead, Early Clinical and Experimental Therapeutics(m/w/x)
Designing early development plans and First-In-Human studies for novel therapeutics. Basic science, translational medicine, or clinical research experience required. Employee benefit programs.
Anforderungen
- Experience in basic science, translational medicine, or clinical research
- Very good communication skills (verbal and written)
- Capability to challenge decisions and status quo with risk-management approach
- Ability to work within a matrix organization
- International/intercultural working skills
- Open-mindedness to apply new digital or AI-driven solutions
- Advanced degree: M.D. or M.D./Ph.D with at least 1-5 years of research experience
- Broad immunology, neurology, or ophthalmology knowledge base
- Knowledge and mindset in translational research
- Ability to acquire and apply new technical skills
- Postgraduate residency training; laboratory research in industry or academia is a plus
- Experience in the conduct of late phase clinical trials
Aufgaben
- Design early development plans and ECET plans for clinical development
- Integrate plans into overall development strategy with Therapeutic Area teams
- Create safe, rapid, and informative First-In-Human studies
- Conduct natural history, experimental model validation, and mechanistic trials
- Supervise study execution and ensure close medical monitoring
- Review and interpret study results
- Author ECET-related clinical documentation
- Interact with managers from various disciplines
- Serve as an expert and internal consultant
- Participate in dose selection for First-In-Human studies
- Drive Go/No Go decisions
- Ensure adequate follow-up of studies and project timelines
- Present data at internal and external meetings
- Maintain Clinical Trial standards
- Ensure high-quality documents
- Manage aggressive timelines through cross-functional planning
- Make front-line decisions on protocol design, execution, and safety
- Coordinate clinical team for study setup and follow-up
- Review and approve study documentation
- Ensure proper documentation for Ethics Committees and Health Authorities
- Prepare and review interim investigator reports
- Lead Dose Escalation Meetings and document decisions
- Review Adverse Event reports
- Participate in data review and validation meetings
- Prepare and distribute Key Results Memos
- Prepare and review Clinical Study Reports
Berufserfahrung
- 1 - 5 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Englisch – verhandlungssicher
Benefits
Mitarbeiterrabatte
- Employee benefit programs
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Sanofi-Aventis Deutschland GmbH
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen bietet Arzneimittel zur Prävention von Herz-Kreislauf-Erkrankungen an und setzt sich für die Verbesserung der Lebensqualität ein.
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