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Lead Scientist, Quantitative Clinical Pharmacology
2 months ago
POSITION OVERVIEW
As a key member of our team, the Lead Scientist - Quantitative Clinical Pharmacology / PK-PD Specialist will concentrate on quantitative clinical pharmacology initiatives across various diseases and therapeutic domains. This role is pivotal in advancing both Early and Late Clinical Development at UCB, collaborating with cross-functional experts to formulate a comprehensive clinical development strategy. You will take charge of leading and executing an integrated PK-PD strategy (focusing on safety and efficacy) for designated projects, guiding the process from candidate selection through to lifecycle management.
Your responsibilities will include:
- Serving as the QCP/PK-PD lead on assigned Clinical Teams and project groups, ensuring that strategic QCP/PK-PD guidance is provided for study plans, designs, dose selections, and relevant operational insights.
- Engaging in Model-Based Drug Development to tackle complex challenges throughout the drug development process, ensuring the integration of PK-PD knowledge on an ongoing basis.
- Assuming the role of Development Scientist lead for the designated project when appropriate.
- Overseeing non-compartmental analysis of PK data, ensuring that essential PK-PD data is generated and analyzed, including population PK, PK-PD modeling, and simulation.
- Offering recommendations for clinical dosing and leading the quantitative clinical pharmacology contributions to regulatory documentation.
- Cultivating and sustaining relationships with external thought leaders and partners in the pharmaceutical sector, ensuring the publication of significant clinical pharmacology studies in reputable journals and presentations at relevant scientific conferences.
- M.D. and/or Ph.D. in a relevant scientific discipline.
- Experience in developing clinical plans with a focus on clinical pharmacology components, including regulatory considerations.
- Comprehensive understanding of pharmacodynamics, translational methods, and population pharmacokinetic-pharmacodynamic modeling.
The ideal candidate will possess essential clinical scientific skills, including:
- Proficiency in Clinical Pharmacology and the application of Modeling & Simulation.
- Ability to interpret clinical effects and understand pharmacological, physiological, and biochemical principles.
- Familiarity with in vivo/in vitro pharmacology.
- Experience in managing PK/PD modeling activities and understanding drug interactions.
- General knowledge of Biopharmaceutics, Biostatistics, and Pharmacogenomics.
The candidate should also demonstrate:
- Strong communication skills to convey quantitative clinical pharmacology activities effectively.
- Capability to contribute to interdisciplinary team discussions and lead sub-teams when necessary.
- Proactive problem-solving abilities and the capacity to anticipate program needs.
- Recognition as a scientific expert both internally and externally.
At UCB, we are committed to fostering an inclusive environment where every individual can thrive and contribute to our mission of creating value for patients.
As an Equal Opportunity Employer, we welcome diverse talent and adhere to principles of Affirmative Action, ensuring that all qualified applicants receive equal consideration for employment.