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BioNTech SE
3mo ago

Director Clinical Operations(m/w/x)

Mainz
Full-timeOn-siteSenior

Description

In this leadership role, you will drive the success of oncology programs by overseeing clinical trial execution, managing vendor partnerships, and mentoring a high-performing operations team.

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Requirements

  • Natural/life sciences or medical background
  • Knowledge of legislation and ICH-GCP guidelines
  • Experience in project management and submissions
  • Refined colloquial and correspondence skills
  • Proficiency in standard office software
  • Readiness to take responsibility
  • Team leadership and motivation skills
  • Problem recognition and solution skills
  • Excellent organizational and communicative skills
  • Independent and proactive working style

Education

Bachelor's degree

Tasks

  • Lead and supervise clinical trial teams
  • Develop portfolio documents and oversight plans
  • Create process developments and trial RACIs
  • Draft and update standard operating procedures
  • Ensure adherence to ICH-GCP and regulatory guidelines
  • Conduct training on relevant clinical procedures
  • Act as the escalation point for project challenges
  • Manage external vendors and sponsor department relations
  • Line manage clinical trial managers and associate directors
  • Plan team resources with the Senior Director
  • Govern and oversee CROs and external vendors
  • Direct vendor selection and strategic sourcing approaches
  • Monitor project timelines and program deliverables
  • Identify and address future program needs
  • Organize and facilitate regular team meetings
  • Identify high-performance members and foster team development
  • Support the QA team during audits and inspections

Tools & Technologies

ICH-GCPWordExcelPowerPointMS Project

Languages

EnglishBusiness Fluent

Benefits

Competitive Pay

  • Competitive remuneration packages
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