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Senior Director Global Clinical Program Lead Cardiovascular & Renal(m/w/x)
Designing global clinical strategies for biotherapeutics in cardiovascular & renal diseases, leading a matrixed Clinical Development Team. MD Board Certification or non-USA equivalent essential; 5+ years clinical development experience needed. Global program leadership, matrix team environment.
Anforderungen
- MD Board Certification or non-USA equivalent
- Clinical development industry experience
- Knowledge of pharmaceutical and regulatory processes
- 5+ years relevant clinical development experience
- Experience of study data review/evaluation
Aufgaben
- Design and execute global clinical strategies
- Lead the Clinical Development Team in a matrix environment
- Develop and manage the Clinical Development Plan
- Coordinate CDT meetings and stakeholder communications
- Ensure compliance with GCP and ICH regulations
- Provide clinical oversight for study development
- Serve as or oversee the medical monitor
- Represent clinical development on cross-functional delivery teams
- Author key documents like protocols and study reports
- Prepare clinical sections for regulatory submissions
- Develop abstracts, presentations, and manuscripts
- Integrate expert contributions into program design
- Maintain alignment across critical stakeholders
- Drive decision making and contingency planning
- Review study data to evaluate safety and efficacy
- Present results to Safety Monitoring Committees
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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Senior Director Global Clinical Program Lead Cardiovascular & Renal(m/w/x)
Designing global clinical strategies for biotherapeutics in cardiovascular & renal diseases, leading a matrixed Clinical Development Team. MD Board Certification or non-USA equivalent essential; 5+ years clinical development experience needed. Global program leadership, matrix team environment.
Anforderungen
- MD Board Certification or non-USA equivalent
- Clinical development industry experience
- Knowledge of pharmaceutical and regulatory processes
- 5+ years relevant clinical development experience
- Experience of study data review/evaluation
Aufgaben
- Design and execute global clinical strategies
- Lead the Clinical Development Team in a matrix environment
- Develop and manage the Clinical Development Plan
- Coordinate CDT meetings and stakeholder communications
- Ensure compliance with GCP and ICH regulations
- Provide clinical oversight for study development
- Serve as or oversee the medical monitor
- Represent clinical development on cross-functional delivery teams
- Author key documents like protocols and study reports
- Prepare clinical sections for regulatory submissions
- Develop abstracts, presentations, and manuscripts
- Integrate expert contributions into program design
- Maintain alignment across critical stakeholders
- Drive decision making and contingency planning
- Review study data to evaluate safety and efficacy
- Present results to Safety Monitoring Committees
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Über das Unternehmen
CSL Behring
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
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