- 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.
- 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
Clinical Pharmacologist/Pharmacometrician - Ghent, België - Argenx
Beschrijving
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:
Competencies and Experience: