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121201 F. Hoffmann-La Roche AG

Senior Clinical Research Scientist(m/w/x)

Basel
Full-timeOn-siteManagement

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

  • EnglishBusiness Fluent
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