CS
CSL Behring
1 Monat

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

Vollzeit
Senior
AI/ML Job
Data Science
Keine Angabe
Opfikon

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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Anforderungen

  • 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
Doktor / Ph.D.

Berufserfahrung

10 Jahre

Deine Aufgaben

  • 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 & Technologien

modeling software

Sprachen

Englischverhandlungssicher

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