Senior Clinical Pharmacologist
il y a 2 semaines
The argenx Quantitative Pharmacology and Pharmacometrics group (QCP²) looks for an experienced clinical pharmacologist to support all aspects of clinical pharmacology, biopharmaceutics and model-based drug development with emphasis on both early and late-phase drug development.
We envision that the experienced clinical pharmacologist will guide us in 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. The pharmacologist will work in close collaboration with the pharmacometrician assigned to the project.
The senior clinical pharmacologist participates in project, including cross-functional team meetings. He/she will interact with clinical scientists and the medical director. He/she will report to the head Quantitative Pharmacology and Pharmacometrics.
Key Accountabilities/Responsibilities:
The senior clinical pharmacologist
- Design and execution of appropriate modeling plans along with the Pharmacometrician assigned to the project.
- Contribute to the design and planning of pre-clinical studies to inform translational modeling.
- 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.
- Keep up-to-date knowledge of model-based drug development with focus on Clinical pharmacology, biopharmaceutics, PKPD & other related analytical sciences including implementation of innovative methods to preclinical research, translational sciences and clinical development.
- Devising and implementing strategy for ensuring an integrated approach for the utilization of expertise through close partnership with preclinical, clinical, and regulatory.
- Coordination of clinical pharmacology related outsourced activities.
Desired skills and Experience:
- A PhD in Biological Sciences, Bioengineering or a related field with 10+ years of experience in pharmaceutical or related fields.
- Fluent in written and spoken English
- Good written and oral communication skills
- A thorough knowledge of the clinical development process
- Ability to drive alignment around his/her vision and strategy across departments
- Excellent knowledge in the pharmacokinetics of mAb based therapeutics and solid understanding of translational sciences
- Understanding of population modeling for analyzing PK/PD data is a plus
- Strong collaborative and interpersonal skills
- Problem solving skills
- Able to motivate external teams
- Flexible, deal with continuous change
**Offer**:
- A competitive salary package with benefits;
- A work environment in a human-sized, dynamic, rapidly growing biotech company.
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