Quantitative Clinical Pharmacology/PK-PD Lead
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- We put our heart, soul and skills into making a difference for people living with severe disease.
- Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?
- To strengthen our Global Exploratory Department, United Kingdom, we are looking to fill the position of: Quantitative Clinical Pharmacology/PK-PD Lead.
- Would you say being strategic and agile are the most importance success factors for you?
- This incomparable blend of talent means you have a visionary flair for changing track deftly to improve patients’ lives
- Act as a QCP/PK-PD lead on assigned CRST and program/project teams, delivering Quantitative Clinical Pharmacology Strategic planning. In particular, ensure that clear strategic QCP/PK-PD direction and input is provided to study level plans, designs, dose selections, PK/PD measures and strategy
- Accountable for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD data are generated and analysed
- Providing recommendations for clinical doses and dosing algorithms to the clinical and Development teams and leading the quantitative clinical pharmacology contributions to all regulatory documents, leads and contributes to the writing and reviewing responses to regulatory queries
- Communicating quantitative clinical pharmacology PK/PD core activities at a project and clinical team level in a manner that promotes productive relationships
- Effectively contributing to interdisciplinary team meetings and, able to effectively leading sub-teams (e.g. QCP) motivating others in a matrix environment
- Anticipating program needs and problem-solve, sharing critical data within the team and the line and proactively proposing solutions
- Ideally Pharm D or PhD
- Demonstrated experience of participating and contributing to the development and execution of the clinical plan, with specific input and expertise in the clinical pharmacology components, including regulatory aspects
- A strong understanding of pharmacodynamics and translational methods, experimental medicine tools, regulatory requirements, population PK-PD modelling and simulation.