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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical pharmacology and pharmacometrics, with a strong focus on pharmacokinetics and pharmacodynamics to guide drug development strategies. Proven ability to lead clinical studies, regulatory submissions, and collaborate with cross-functional teams.
Highest-signal resume keywords
PhD Or PharmD In Clinical PharmacologyClinical Pharmacology Research FellowshipExtensive Experience In Clinical PharmacologyPharmacokinetic And PK-PD Data AnalysisPharmacometrics Methodologies And Modeling
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical PharmacologyPharmacokineticsPharmacodynamicsPK-PD StrategyClinical Trial DesignPopulation Pharmacokinetic MethodologiesPharmacometrics MethodologiesModeling And SimulationRegulatory SubmissionsData Interpretation
Soft Skills
Scientific OversightCollaborationRelationship ManagementCommunication
Industry Keywords
Clinical DevelopmentClinical Research OperationsHealth Authority QuestionsInvestigator’s BrochuresRegulatory Documentation
About the role
Key responsibilities & impact- Lead clinical pharmacology and PK-PD strategies for assigned programs across the R&D portfolio
- Lead the design of clinical pharmacology studies and relevant protocol sections across all 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
- Lead review and interpretation of clinical pharmacology study results
- 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
- Apply pharmacometric methodologies, including modeling and simulation, 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 written responses to health authority questions and contribute to regulatory meetings and filing activities
- Partner with Research and Translational Science teams on preclinical PK-PD knowledge and early clinical study design
- Establish and maintain relationships with external scientific experts and key opinion leaders
Requirements
What you’ll need- PhD or PharmD in Clinical Pharmacology, Pharmacology, Pharmaceutical Sciences, or a related scientific discipline
- A clinical pharmacology research fellowship is preferred
- Minimum of 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 the use of biomarkers to 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
Benefits
Comp & perks- CSL benefits are provided; details available via “How CSL Supports Your Well-being | CSL”
- Inclusion and Belonging culture
- Reasonable accommodation for applicants with disabilities