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CSL Behring
2mo ago

Director Pharmacokinetics (PK) & Quantitate Systems Pharmacology (QSP)(m/w/x)

Opfikon
Full-timeOn-siteSenior
AI/ML
Data Science

Description

In this role, you will lead the design and execution of pharmacokinetic and quantitative systems pharmacology modeling strategies, collaborating with cross-functional teams to support drug development and enhance regulatory confidence.

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Requirements

  • •Ph.D. in Pharmacokinetics, Systems Pharmacology, Pharmacometrics, Biomedical Engineering, or related field
  • •10+ years of pharmaceutical industry experience in PK/PD, PBPK, and/or QSP modeling
  • •Proven track record of applying modeling to support drug development and regulatory submissions
  • •Proficiency in modeling software for PK/PD, PBPK, QSP
  • •Strong understanding of ADME, pharmacology, and translational science
  • •Excellent communication, leadership, and project management skills
  • •Experience with omics data integration, machine learning, or AI-enhanced modeling is a plus
  • •Ability to manage multiple projects and timelines
  • •Experience across multiple therapeutic areas and modalities is highly desirable

Education

Doctoral / PhD

Work Experience

10 years

Tasks

  • •Lead the development of integrated PK, PBPK, and QSP modeling strategies
  • •Serve as the subject matter expert in modeling and simulation
  • •Advise project teams on study design, dose selection, and risk assessment
  • •Champion model-informed drug development approaches
  • •Design and execute nonclinical PK and TK studies
  • •Design and execute PBPK and QSP modeling strategies
  • •Act as the senior PK/QSP lead on therapeutic area teams
  • •Collaborate with Research and Nonclinical development functions
  • •Align pharmacokinetic and modeling strategies with program goals
  • •Provide scientific input and modeling insights in project teams
  • •Offer expert input for due diligence on in-licensing opportunities
  • •Review Nonclinical Pharmacokinetic sections for submission documents
  • •Prepare and review modeling reports and regulatory documents
  • •Stay updated on trends and regulatory expectations in PK, PBPK, and QSP modeling
  • •Contribute to scientific publications and conference presentations
  • •Lead and mentor a team of Principal and Senior scientists
  • •Foster a culture of scientific excellence and continuous learning

Tools & Technologies

modeling software

Languages

English – Business Fluent

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