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Clinical Development Director (Neuroscience)(m/w/x)
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 7 years
Education
- Master's degree
Languages
- English – Business Fluent
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Clinical Development Director (Neuroscience)(m/w/x)
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 7 years
Education
- Master's degree
Languages
- English – Business Fluent
About the Company
Novartis Pharma AG
Industry
Pharmaceuticals
Description
Das Unternehmen setzt sich für Vielfalt, Chancengleichheit und Inklusion ein und fördert innovative Lösungen zur Verbesserung der Patientenversorgung.
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