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(Senior-) Director Clinical Development(m/w/x)
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
- English – Business Fluent
Tools & Technologies
- NDA submissions
- Companion diagnostics
- Translational modeling
- Biostatistics
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(Senior-) Director Clinical Development(m/w/x)
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
- English – Business Fluent
Tools & Technologies
- NDA submissions
- Companion diagnostics
- Translational modeling
- Biostatistics
About the Company
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
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