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NONovartis Pharma AG

Clinical Development Director (Neuroscience)(m/w/x)

Basel
Full-timeWith Home OfficeSenior

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

  • EnglishBusiness Fluent
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