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Director Pharmacokinetics (PK) & Quantitate Systems Pharmacology (QSP)(m/w/x)
Beschreibung
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.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
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
Ausbildung
Berufserfahrung
10 Jahre
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
Sprachen
Englisch – verhandlungssicher
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Director Pharmacokinetics (PK) & Quantitate Systems Pharmacology (QSP)(m/w/x)
Die KI-Suchmaschine für Jobs
Beschreibung
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.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
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
Ausbildung
Berufserfahrung
10 Jahre
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
Sprachen
Englisch – verhandlungssicher
Über das Unternehmen
CSL Behring
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
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