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BIBioNTech SE

(Senior-) Director Clinical Development(m/w/x)

Mainz, München
Full-timeOn-siteSenior

Clinical trial plan design for new Immuno-Oncology/Oncology compounds at a biotech developing groundbreaking medicines. M.D. degree with Immuno-Oncology/Oncology background and Phase I-III program leadership experience required. Strategic program leadership, global health authority interaction.

Requirements

  • M.D. degree with Immuno-Oncology or Oncology background
  • Experience leading Phase I–III clinical programs
  • Expertise in advanced clinical study designs
  • Experience interacting with global health authorities
  • Medical acumen in safety/efficacy monitoring
  • Exceptional leadership and mentoring skills

Tasks

  • Design clinical trial plans for new compounds
  • Manage studies from early exploration through regulatory approval
  • Operationalize clinical strategies for assigned portfolios
  • Lead core teams as the Program Lead
  • Drive program strategy and prepare submission processes
  • Oversee medical safety and risk-benefit assessments
  • Address medical queries to ensure patient safety
  • Integrate digital endpoints and real-world evidence into trials
  • Develop Investigator’s Brochures and Clinical Study Reports
  • Author high-quality New Drug Applications
  • Foster relationships with external stakeholders
  • Represent the clinical team in governance meetings

Education

  • Doctoral / PhD

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • NDA submissions
  • Companion diagnostics
  • Translational modeling
  • Biostatistics
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE 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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