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Global Head Mechanistic Safety and Safety Signal Management(m/w/x)
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
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
- Französisch – Grundkenntnisse
Noch nicht perfekt?
- NovartisVollzeitnur vor OrtSeniorBasel
- Roche
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Global Head Mechanistic Safety and Safety Signal Management(m/w/x)
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
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
- Französisch – Grundkenntnisse
Über das Unternehmen
Novartis Pharma AG
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen setzt sich für Vielfalt, Chancengleichheit und Inklusion ein und fördert innovative Lösungen zur Verbesserung der Patientenversorgung.
Noch nicht perfekt?
- Novartis
Global Program Safety Lead(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Senior Vice President - Global Head of Safety Risk Management(m/w/x)
Vollzeitnur vor OrtManagementBasel - Novartis
Global Program Safety Team Lead(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Idorsia Pharmaceuticals Ltd
Drug Safety Scientist(m/w/x)
Vollzeitnur vor OrtSeniorAllschwil - Roche
Global Head of Product Development Regulatory(m/w/x)
Vollzeitnur vor OrtSeniorBasel