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BOBoehringer Ingelheim

Safety Science Lead(m/w/x)

Biberach
Part-timeOn-siteExperienced

Developing nonclinical testing strategies and toxicological assessments for CRM therapeutic area. PhD and several years of regulatory nonclinical drug safety experience required. Support for scientifically robust project strategies and alignment with external requirements.

Requirements

  • PhD or equivalent degree in Human Medicine, Veterinary Medicine, Biochemistry, Biology, or comparable training/education
  • Several years of experience in regulatory nonclinical drug safety for human pharmaceuticals, including expert authoring of regulatory documents (IB or CTDs)
  • Ability to handle complexity in drug development and interface management
  • Training in toxicology (board certificate), pathology (board certificate), or comparable experience
  • Fluency in English, spoken and written
  • Applications from persons with severe disabilities warmly welcomed; preferential consideration in selection process for equal qualifications

Tasks

  • Serve as Safety Science Lead or CPS Lead for CRM therapeutic area
  • Develop nonclinical testing strategies and toxicological assessments
  • Prepare regulatory documents for CRM therapeutic area
  • Support scientifically robust non-clinical safety project strategies
  • Align strategies with external requirements and benchmark project strategies
  • Plan, conduct, and oversee nonclinical safety development programs
  • Focus on new entities in CRM therapeutic area
  • Generate concise nonclinical safety assessments for internal decisions
  • Prepare regulatory submission documentation for health authority reviews
  • Facilitate approval processes in pre-clinical and clinical drug development
  • Conduct toxicological qualification of impurities

Work Experience

  • approx. 1 - 4 years

Education

  • Vocational certification

Languages

  • EnglishFluent
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