Director Clinical Pharmacology

CSL

1d•Hybrid

About The Position

CSL is seeking a Director, Clinical Pharmacology to provide clinical pharmacology and pharmacometrics expertise across programs in its R&D portfolio. The Director will lead clinical pharmacology strategy, guide pharmacokinetic/pharmacodynamic (PK-PD) assessments, and apply modeling and simulation to support drug development decisions throughout the clinical development lifecycle. The role operates with a high degree of independence and works closely with clinical development, research, translational science, biostatistics, and other R&D partners to integrate clinical pharmacology strategies into global development plans. The Director also represents clinical pharmacology in regulatory interactions and contributes to submission documents, regulatory responses, and health-authority discussions to support development and registration of therapies. The position is based in King of Prussia, Pennsylvania, or Glattbrugg, Switzerland, with a hybrid arrangement requiring three days onsite.

Requirements

PhD or PharmD in Clinical Pharmacology, Pharmacology, Pharmaceutical Sciences, or a related scientific discipline.
At least 8 years of relevant industry experience for Director-level candidates with a PhD or PharmD, specifically contributing to clinical pharmacology aspects of clinical drug development.
Extensive experience in clinical pharmacology, particularly pharmacokinetics, pharmacodynamics, and PK-PD strategy.
Experience supporting clinical drug development programs across relevant stages of development.
Advanced understanding of clinical pharmacology principles, including clinical trial design and conduct.
Strong knowledge of pharmacokinetic and PK-PD data analysis, interpretation, and application in drug development.
Experience with population pharmacokinetic methodologies and interpretation of related analyses.
Understanding of how biomarkers inform clinical development decisions.
Demonstrated technical expertise in pharmacometrics methodologies and their practical application, including modeling and simulation.
Experience contributing to regulatory submissions, clinical pharmacology documentation, and responses to health-authority questions.
Ability to integrate clinical and nonclinical data to inform dose selection, study design, and clinical development strategies.

Nice To Haves

Clinical pharmacology research fellowship.

Responsibilities

Lead clinical pharmacology and PK-PD strategies for assigned programs across the R&D portfolio in partnership with pharmacometricians, clinical program directors, clinical scientists, biostatisticians, and other colleagues.
Lead the design of clinical pharmacology studies and relevant protocol sections across stages of drug development; provide scientific oversight of study implementation with Clinical Development, Clinical Safety, and Clinical Research Operations.
Plan and implement pharmacokinetic and pharmacodynamic analyses, including non-compartmental analysis and other relevant approaches, to inform clinical development decisions.
Lead review and interpretation of clinical pharmacology study results and ensure high-quality presentation and documentation in clinical study reports, scientific publications, and related study materials.
Represent clinical pharmacology and pharmacometrics on clinical development teams and integrate clinical pharmacology strategies into global development plans.
Apply pharmacometric methodologies, including modeling and simulation, to integrate pharmacokinetics, pharmacodynamics, patient characteristics, and disease states; use findings to inform dose selection, study design, and development strategies.
Provide clinical pharmacology expertise for protocols, Investigator’s Brochures, regulatory submissions, product labeling, and other regulatory documentation.
Lead development of clinical pharmacology strategies and written responses to health-authority questions; contribute to regulatory meetings and filing activities as needed.
Partner with Research and Translational Science teams to develop preclinical PK-PD knowledge supporting early clinical development and incorporate pharmacology and toxicology data into early clinical study design.
Establish and maintain relationships with external scientific experts and key opinion leaders in clinical pharmacology to support scientific exchange and advance development approaches.