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SASanofi-Aventis Deutschland GmbH

Clinical Lead, Early Clinical and Experimental Therapeutics(m/w/x)

Frankfurt am Main
ab 101.040 - 134.720 / Jahr
Vollzeitmit HomeofficeJunior
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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

  • Englischverhandlungssicher

Benefits

Mitarbeiterrabatte

  • Employee benefit programs
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