CSL Behring
Senior Scientist, Pharmacokinetics (PK)(m/w/x)
Vollzeitnur vor OrtSenior
Glattbrugg
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CSCSL Behring
Principal Scientist, Pharmacokinetics (PK)(m/w/x)
Glattbrugg
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Designing and leading nonclinical QSP strategies for biotherapeutic drug development at a global biotherapeutics leader. 5+ years pharmaceutical development experience, with modeling/simulation and Phoenix WinNonLin, NONMEM, R skills essential. Focus on innovative therapies for immunology, hematology, and cardiovascular areas.
Anforderungen
- PhD in Pharmaceutical Sciences or related subject area
- Minimum 5+ years pharmaceutical development experience in pharma, biotech, or CRO
- Focus on modeling and simulation
- Training in PK/PD, modeling and simulation
- Experience with Phoenix WinNonLin, NONMEM, R
- Proven track record in nonclinical PK/QSP assessments
- Proven track record in regulatory submissions
- Strong understanding of GLP regulations
- Strong understanding of ICH guidelines
- Strong understanding of global regulatory requirements
- Excellent communication skills
- Leadership skills
- Cross-functional collaboration skills
- Experience with CSL’s disease therapeutic areas
- Highly desirable experience across multiple therapeutic areas and modalities
- Experience in multicultural and international teams
Aufgaben
- Lead nonclinical PK/QSP strategies
- Manage nonclinical PK/QSP strategies
- Represent PK/ADME/QSP on project teams
- Provide scientific leadership for drug development
- Design non-clinical PK/QSP studies
- Budget non-clinical PK/QSP studies
- Monitor non-clinical PK/QSP studies
- Represent Nonclinical Development in research teams
- Monitor external PK studies
- Apply advanced PK/PD modeling principles
- Perform advanced PK/PD modeling
- Define dose-concentration-efficacy/toxicity relationships
- Formulate study design scenarios
- Predict study outcomes
- Lead study design discussions
- Develop study protocols
- Perform sample size calculations
- Develop data analysis plans
- Report population PK analysis results
- Report PK/PD analysis results to management
- Provide technical guidance to team
- Mentor junior team members
- Maintain relationships with colleagues
- Collaborate with internal and external colleagues
- Support selection of PK CROs
- Establish academic collaborations
- Maintain academic collaborations
- Present integrated PK/QSP assessments
Berufserfahrung
- 5 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Phoenix WinNonLin
- NONMEM
- R
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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CSCSL Behring
Principal Scientist, Pharmacokinetics (PK)(m/w/x)
Glattbrugg
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Designing and leading nonclinical QSP strategies for biotherapeutic drug development at a global biotherapeutics leader. 5+ years pharmaceutical development experience, with modeling/simulation and Phoenix WinNonLin, NONMEM, R skills essential. Focus on innovative therapies for immunology, hematology, and cardiovascular areas.
Anforderungen
- PhD in Pharmaceutical Sciences or related subject area
- Minimum 5+ years pharmaceutical development experience in pharma, biotech, or CRO
- Focus on modeling and simulation
- Training in PK/PD, modeling and simulation
- Experience with Phoenix WinNonLin, NONMEM, R
- Proven track record in nonclinical PK/QSP assessments
- Proven track record in regulatory submissions
- Strong understanding of GLP regulations
- Strong understanding of ICH guidelines
- Strong understanding of global regulatory requirements
- Excellent communication skills
- Leadership skills
- Cross-functional collaboration skills
- Experience with CSL’s disease therapeutic areas
- Highly desirable experience across multiple therapeutic areas and modalities
- Experience in multicultural and international teams
Aufgaben
- Lead nonclinical PK/QSP strategies
- Manage nonclinical PK/QSP strategies
- Represent PK/ADME/QSP on project teams
- Provide scientific leadership for drug development
- Design non-clinical PK/QSP studies
- Budget non-clinical PK/QSP studies
- Monitor non-clinical PK/QSP studies
- Represent Nonclinical Development in research teams
- Monitor external PK studies
- Apply advanced PK/PD modeling principles
- Perform advanced PK/PD modeling
- Define dose-concentration-efficacy/toxicity relationships
- Formulate study design scenarios
- Predict study outcomes
- Lead study design discussions
- Develop study protocols
- Perform sample size calculations
- Develop data analysis plans
- Report population PK analysis results
- Report PK/PD analysis results to management
- Provide technical guidance to team
- Mentor junior team members
- Maintain relationships with colleagues
- Collaborate with internal and external colleagues
- Support selection of PK CROs
- Establish academic collaborations
- Maintain academic collaborations
- Present integrated PK/QSP assessments
Berufserfahrung
- 5 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Phoenix WinNonLin
- NONMEM
- R
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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.
Noch nicht perfekt?
- CSL Behring
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Director Pharmacokinetics (PK) & Quantitate Systems Pharmacology (QSP)(m/w/x)
Vollzeitnur vor OrtSeniorOpfikon - CSL Plasma
Principal Scientist, Regulatory Toxicology(m/w/x)
Vollzeitnur vor OrtSeniorOpfikon - CSL Behring
Principal Scientist, Toxicology(m/w/x)
Vollzeitnur vor OrtSeniorOpfikon