CSL Plasma Inc.
Senior Director, Toxicology & Pharmacokinetics
CSL Plasma Inc., Indiana, Pennsylvania, us, 15705
Senior Director, Toxicology & Pharmacokinetics page is loaded## Senior Director, Toxicology & Pharmacokineticslocations:
EMEA, CH, Glattbrugg, CSL Behringtime type:
Vollzeitposted on:
Vor mehr als 30 Tagen ausgeschriebentime left to apply:
Enddatum: 25. Dezember 2025 (Noch 30+ Tage Zeit für Bewerbung)job requisition id:
R-260519The Senior Director of Nonclinical Toxicology & Pharmacokinetics is responsible for overseeing the strategic direction, execution, and integration of nonclinical safety, pharmacokinetics (PK), and advanced modeling—including Quantitative Systems Pharmacology (QSP) to support drug development from discovery through clinical stages across all Therapeutic Areas. This role ensures that all Toxicology and Pharmacokinetic data support regulatory submissions and clinical development and thereby enable effective FIH transition and provide data-driven insights to inform decision-making.Strategic Leadership:
Lead the nonclinical safety and PK/QSP strategy across all therapeutic areas.
Drive the integration of Tox/PK data into broader R&D strategies.
Serve as a key member of the NCD leadership team, contributing to strategy decisions, data review and risk assessments
Provides technical reports and advice to senior management, planning and engineering personnelScientific Oversight:
Oversee the design, execution, and interpretation of toxicology, ADME/PK/QSP/PBPK studies performed at CROs and provide scientific rationale and data interpretation for advancing candidates into early clinical development.
Lead Early Nonclinical Safety Assessments.
Guide the development and application of modeling approaches (e.g., QSP, PBPK, PK/PD) to support dose selection and nonclinical and clinical trial design.
Ensure integration of nonclinical data into clinical development plans and regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs).
Ensure compliance with GLP and ICH guidelines for nonclinical studies.Cross-functional Collaboration:
Collaborate with relevant R&D functions to align Tox/PK insights and strategies with development goals.
Provide expert input into due diligence for in-licensing or partnership opportunities.
Collaborate with External Study Management for study execution at CROs.
Present findings at internal meetings, scientific conferences, and in peer-reviewed publications.Team Leadership:
Build and mentor a multidisciplinary team of toxicologists, pharmacokineticists, and modelers.
Foster a culture of scientific excellence, innovation, and continuous learning.Responsible for leadership and development of toxicology research employees at multiple relevant R&D locations
PhD, DVM, or PharmD in Toxicology, Pharmacology, Pharmaceutical Sciences, or related field.
12+ years of experience in nonclinical drug development within the pharmaceutical or biotech industry with proven and deep understanding of pharmaceutical development-scientific and people leadership
Experience with a range of therapeutic modalities (e.g., small molecules, biologics) is a plus.
Proven expertise in toxicology, PK, and modeling (including QSP and PBPK)
Proven track record of leading cross-functional teams and managing complex development programs.
Deep understanding of regulatory requirements and industry best practices in toxicology and PK.
Strong leadership, communication, and cross-functional collaboration skills.
Proven experience leading cross-functional, multicultural and international product development teams
Excellent communication skills (English language)## **Was wir bieten**Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, .## **Über CSL Behring**CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über .## **CSL soll so vielfältig sein wie die Welt, in der wir leben**Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über
bei CSL.## **Machen Sie mit Ihrer Arbeit bei CSL einen Unterschied!** #J-18808-Ljbffr
EMEA, CH, Glattbrugg, CSL Behringtime type:
Vollzeitposted on:
Vor mehr als 30 Tagen ausgeschriebentime left to apply:
Enddatum: 25. Dezember 2025 (Noch 30+ Tage Zeit für Bewerbung)job requisition id:
R-260519The Senior Director of Nonclinical Toxicology & Pharmacokinetics is responsible for overseeing the strategic direction, execution, and integration of nonclinical safety, pharmacokinetics (PK), and advanced modeling—including Quantitative Systems Pharmacology (QSP) to support drug development from discovery through clinical stages across all Therapeutic Areas. This role ensures that all Toxicology and Pharmacokinetic data support regulatory submissions and clinical development and thereby enable effective FIH transition and provide data-driven insights to inform decision-making.Strategic Leadership:
Lead the nonclinical safety and PK/QSP strategy across all therapeutic areas.
Drive the integration of Tox/PK data into broader R&D strategies.
Serve as a key member of the NCD leadership team, contributing to strategy decisions, data review and risk assessments
Provides technical reports and advice to senior management, planning and engineering personnelScientific Oversight:
Oversee the design, execution, and interpretation of toxicology, ADME/PK/QSP/PBPK studies performed at CROs and provide scientific rationale and data interpretation for advancing candidates into early clinical development.
Lead Early Nonclinical Safety Assessments.
Guide the development and application of modeling approaches (e.g., QSP, PBPK, PK/PD) to support dose selection and nonclinical and clinical trial design.
Ensure integration of nonclinical data into clinical development plans and regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs).
Ensure compliance with GLP and ICH guidelines for nonclinical studies.Cross-functional Collaboration:
Collaborate with relevant R&D functions to align Tox/PK insights and strategies with development goals.
Provide expert input into due diligence for in-licensing or partnership opportunities.
Collaborate with External Study Management for study execution at CROs.
Present findings at internal meetings, scientific conferences, and in peer-reviewed publications.Team Leadership:
Build and mentor a multidisciplinary team of toxicologists, pharmacokineticists, and modelers.
Foster a culture of scientific excellence, innovation, and continuous learning.Responsible for leadership and development of toxicology research employees at multiple relevant R&D locations
PhD, DVM, or PharmD in Toxicology, Pharmacology, Pharmaceutical Sciences, or related field.
12+ years of experience in nonclinical drug development within the pharmaceutical or biotech industry with proven and deep understanding of pharmaceutical development-scientific and people leadership
Experience with a range of therapeutic modalities (e.g., small molecules, biologics) is a plus.
Proven expertise in toxicology, PK, and modeling (including QSP and PBPK)
Proven track record of leading cross-functional teams and managing complex development programs.
Deep understanding of regulatory requirements and industry best practices in toxicology and PK.
Strong leadership, communication, and cross-functional collaboration skills.
Proven experience leading cross-functional, multicultural and international product development teams
Excellent communication skills (English language)## **Was wir bieten**Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, .## **Über CSL Behring**CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über .## **CSL soll so vielfältig sein wie die Welt, in der wir leben**Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über
bei CSL.## **Machen Sie mit Ihrer Arbeit bei CSL einen Unterschied!** #J-18808-Ljbffr