Clinical Pharmacologist/Pharmacometrician

Clinical Pharmacologist/Pharmacometrician

argenx

Ghent, Belgium

As member of Quantitative Clinical Pharmacology and Pharmacometrics (QCP²), the Clinical Pharmacologist/Pharmacometrician will support aspects of clinical pharmacology and responsible for supervising and conducting population PK/PD modeling and simulation activities with emphasis on both early and late-phase drug development.

Principal Responsibilities:

• Developing and executing CP development strategy in supporting the selection of the right dose-regimen, in the right population, using the relevant biomarkers and the right endpoint to achieve differentiation and develop a CP package that enables global product registration;
• Contribute to the design and dose selection of the FIH study (SAD, MAD);
• Contribute to the required components of regulatory submissions and be responsible for responding to regulatory authority queries;
• Will drive early alignment on key development questions where CP principles could be applied;
• Actively participate in project discussions with project teams to understand the scope and need for QCP² involvement and develop appropriate plans that address the key development questions;
• Attend governance meetings, as necessary, ensure that CP plans are flawlessly executed, on time for efficient decision making;
• Supports product development by defining dose-concentration-pharmacological effect relationships of a drug using modeling & simulation methodologies from data acquired at various development stages (Phase 1-3);
• Develops & reviews study designs, writes analysis plans & reports, analyses and interprets PK/PD data and results;
• Devising and implementing strategy for ensuring an integrated approach for the utilization of expertise through close partnership with preclinical, clinical, and regulatory;
• Identifies opportunities and ways to address drug development questions/issues;
• Coordination of clinical pharmacology/pharmacometrics related outsourced activities.

Competencies and Experience:

• A PhD in Biological Sciences, Bioengineering or a related field with 15+ years of experience in pharmaceutical or related fields;
• Fluent in written and spoken English;
• Good written and oral communication skill;
• Self motivated with the ability to work independently with minimal supervision (personal accountability);
• In-depth knowledge and understanding of innovative approaches in clinical pharmacokinetics, clinical pharmacology, PK and PK-PD modeling approaches and their applications in model based drug development;
• Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner (planning, organizing and time management);
• Ability to drive alignment around his/her vision and strategy across departments.

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