1201 F. Hoffmann-La Roche AG
Clinical Scientist immunology(m/w/x)
Full-timeOn-siteSenior
Basel
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121201 F. Hoffmann-La Roche AG
Senior Clinical Research Scientist(m/w/x)
Basel
Full-timeOn-siteManagement
Nejo AI Summary
Overseeing Medical Data Review Plan execution and developing trial strategy for late-stage clinical development at a global pharma company. Extensive late-stage clinical development experience required; Advanced Clinical/Science Degree preferred. Work across cross-functional teams in a global pharma setting.
Requirements
- Bachelor’s degree in life sciences
- Advanced Clinical/Science Degree preferred
- Extensive academic or industry experience in late stage clinical development
- Strong knowledge of GCP, ICH, FDA, EMA guidelines
- In-depth knowledge of cross-functional teams in drug development
- Proven track record in a fast-paced, matrix environment
- Experience with Study Management Team (SMT)
- Experience as co-lead with various stakeholders
- Experience leading and mentoring others
- Experience solving unique or unpredictable problems
- Ability to partner across diverse regions and cultures
- Strong verbal communication and influencing skills
Tasks
- Oversee Medical Data Review Plan execution
- Manage database lock and data interpretation
- Ensure effective execution of the Clinical Development Plan
- Develop trial and protocol strategy within the broader CDP
- Ensure appropriate data is reflected in protocols, ICFs, and CSR
- Establish clinical science strategy for CTA/EC submissions
- Prepare briefing packs and responses to health authority questions
- Collaborate with filing team and stakeholders on CDP context
- Act independently with investigators and oversee investigator meetings
- Contribute to Therapeutic Area Expert interactions for clinical program optimization
- Manage relationships with external partnerships and institutions
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 1201 F. Hoffmann-La Roche AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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121201 F. Hoffmann-La Roche AG
Senior Clinical Research Scientist(m/w/x)
Basel
Full-timeOn-siteManagement
Nejo AI Summary
Overseeing Medical Data Review Plan execution and developing trial strategy for late-stage clinical development at a global pharma company. Extensive late-stage clinical development experience required; Advanced Clinical/Science Degree preferred. Work across cross-functional teams in a global pharma setting.
Requirements
- Bachelor’s degree in life sciences
- Advanced Clinical/Science Degree preferred
- Extensive academic or industry experience in late stage clinical development
- Strong knowledge of GCP, ICH, FDA, EMA guidelines
- In-depth knowledge of cross-functional teams in drug development
- Proven track record in a fast-paced, matrix environment
- Experience with Study Management Team (SMT)
- Experience as co-lead with various stakeholders
- Experience leading and mentoring others
- Experience solving unique or unpredictable problems
- Ability to partner across diverse regions and cultures
- Strong verbal communication and influencing skills
Tasks
- Oversee Medical Data Review Plan execution
- Manage database lock and data interpretation
- Ensure effective execution of the Clinical Development Plan
- Develop trial and protocol strategy within the broader CDP
- Ensure appropriate data is reflected in protocols, ICFs, and CSR
- Establish clinical science strategy for CTA/EC submissions
- Prepare briefing packs and responses to health authority questions
- Collaborate with filing team and stakeholders on CDP context
- Act independently with investigators and oversee investigator meetings
- Contribute to Therapeutic Area Expert interactions for clinical program optimization
- Manage relationships with external partnerships and institutions
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 1201 F. Hoffmann-La Roche AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
1201 F. Hoffmann-La Roche AG
Industry
Healthcare
Description
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
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