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NONovartis Pharma AG

Global Head Mechanistic Safety and Safety Signal Management(m/w/x)

Basel
VollzeitVor OrtSenior

Leading enterprise-wide mechanistic safety strategy and signal management for drug development at a global pharma company. Medical degree and extensive drug development experience required. Strategic leadership across global development teams.

Anforderungen

  • Medical degree, strong clinical sciences and patient safety grounding
  • Fluent English (spoken and written)
  • Experience in clinical trials (phases 1, 2, 3)
  • Extensive drug development experience (preclinical and clinical stages)
  • Expertise in preparing or contributing to clinical and safety assessments and regulatory safety submissions
  • Leadership in cross-functional, multicultural teams (matrix environment)
  • Strong capability in managing complex safety issues
  • Deep understanding of clinical trial methodology, regulatory expectations, scientific approaches, publication development
  • Track record of peer-reviewed scientific publications
  • Exceptional communication and stakeholder engagement skills
  • Specialty Board Certification (Internal Medicine, Clinical Pharmacology and Toxicology, Gastroenterology, or Cardiology)
  • Understanding of additional major language (German or French)
  • Additional experience with statistical methods
  • Cross Functional Teams
  • Medical Strategy
  • Process Safety Management
  • Regulatory Compliance
  • Safety Science

Aufgaben

  • Lead enterprise-wide mechanistic safety strategy
  • Anticipate, evaluate, and address emerging safety risks
  • Chair the Medical Safety Review Board
  • Guide rapid, scientifically sound safety decisions
  • Provide expert leadership to development teams
  • Strengthen safety insights from research to post-marketing
  • Drive mechanistic investigation of safety signals
  • Inform project progression and risk mitigation
  • Oversee coordination of mechanistic activities
  • Coordinate across development, research, and clinical functions
  • Guide development and review of Risk Management Plans
  • Guide development and review of safety mitigation strategies
  • Evaluate safety findings from preclinical and clinical projects
  • Foster collaboration with safety expert panels
  • Ensure highest standards of scientific quality
  • Lead and develop mechanistic safety associates
  • Nurture expertise and scientific excellence
  • Build impactful internal and external partnerships
  • Advance innovative safety methodologies and best practices

Berufserfahrung

  • ca. 4 - 6 Jahre

Ausbildung

  • Bachelor-Abschluss

Sprachen

  • Englischverhandlungssicher
  • DeutschGrundkenntnisse
  • FranzösischGrundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharma AG 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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