Novartis Pharma AG
Clinical Development Director (Neuroscience)(m/w/x)
Vollzeitmit HomeofficeSenior
Basel
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NONovartis Pharma AG
Clinical Development Director (Neuroscience)(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading clinical development strategies and regulatory document creation for rare disease programs. 7+ years in clinical research or drug development, with advanced therapeutic area knowledge required. Focus on innovative patient care solutions.
Anforderungen
- Advanced degree in life sciences, healthcare, or clinically relevant degree
- Background or experience in Neuroscience, Neurodegeneration, Neuromuscular, Gene Therapy, Rare diseases, Neuroinflammation or similar
- Fluent oral and written English
- At least 7 years of involvement in clinical research or drug development
- Advanced knowledge of assigned therapeutic area
- Demonstrated ability to establish strong scientific partnership with key stakeholders
- Thorough knowledge of GCP, clinical trial design and methodology, statistical analysis methodology, and regulatory/clinical development process
- At least 1 year of people management experience or management in a matrix environment
- Excellent communication skills, written and oral
- Excellent interpersonal skills
- Excellent negotiation and conflict resolution skills
- Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management, Risk Monitoring
Aufgaben
- Support and lead delivery of clinical deliverables in assigned program sections
- Develop clinical development strategies for assigned program sections
- Review clinical data and ensure compliance with program-specific standards
- Contribute to the development of Clinical Study Reports (CSRs) and publications
- Lead the creation of regulatory documents like Investigator’s Brochures and safety updates
- Conduct ongoing reviews of clinical trial data with medical monitors and experts
- Collaborate with data management and statistics teams for data quality and analysis
- Prepare for inspections and audits, including risk assessments and mock interviews
- Author and review abstracts, presentations, and manuscripts for clinical accuracy
- Support monitoring and safety data analysis for assigned clinical trial sections
- Engage with external stakeholders such as regulatory authorities and advisory boards
- Facilitate the transition of pre-PoC projects to Development Decision Point
- Ensure career development and mentoring for clinical colleagues
- Provide medical/scientific training to Novartis stakeholders
- Lead global initiatives for process improvement and training
- Serve as Clinical Scientific Lead for clinical trials, guiding all clinical aspects
Berufserfahrung
- 7 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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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NONovartis Pharma AG
Clinical Development Director (Neuroscience)(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading clinical development strategies and regulatory document creation for rare disease programs. 7+ years in clinical research or drug development, with advanced therapeutic area knowledge required. Focus on innovative patient care solutions.
Anforderungen
- Advanced degree in life sciences, healthcare, or clinically relevant degree
- Background or experience in Neuroscience, Neurodegeneration, Neuromuscular, Gene Therapy, Rare diseases, Neuroinflammation or similar
- Fluent oral and written English
- At least 7 years of involvement in clinical research or drug development
- Advanced knowledge of assigned therapeutic area
- Demonstrated ability to establish strong scientific partnership with key stakeholders
- Thorough knowledge of GCP, clinical trial design and methodology, statistical analysis methodology, and regulatory/clinical development process
- At least 1 year of people management experience or management in a matrix environment
- Excellent communication skills, written and oral
- Excellent interpersonal skills
- Excellent negotiation and conflict resolution skills
- Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management, Risk Monitoring
Aufgaben
- Support and lead delivery of clinical deliverables in assigned program sections
- Develop clinical development strategies for assigned program sections
- Review clinical data and ensure compliance with program-specific standards
- Contribute to the development of Clinical Study Reports (CSRs) and publications
- Lead the creation of regulatory documents like Investigator’s Brochures and safety updates
- Conduct ongoing reviews of clinical trial data with medical monitors and experts
- Collaborate with data management and statistics teams for data quality and analysis
- Prepare for inspections and audits, including risk assessments and mock interviews
- Author and review abstracts, presentations, and manuscripts for clinical accuracy
- Support monitoring and safety data analysis for assigned clinical trial sections
- Engage with external stakeholders such as regulatory authorities and advisory boards
- Facilitate the transition of pre-PoC projects to Development Decision Point
- Ensure career development and mentoring for clinical colleagues
- Provide medical/scientific training to Novartis stakeholders
- Lead global initiatives for process improvement and training
- Serve as Clinical Scientific Lead for clinical trials, guiding all clinical aspects
Berufserfahrung
- 7 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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.
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 Pharma AG
Clinical Development Director (Neuroscience)(m/w/x)
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