My client is seeking a Director of Pharmacometrics to be based in Switzerland on a permanent basis. This role will provide strategic and operational accountability and oversight on PK / PD related topics for the development pipeline including input to modelling. This expertise and input should essentially support the clinical development and Biostatics team to anticipate and plan the best path forward for phase I programs where limited information on the key PK parameters may be available.
- Provide strategic and operational guidance on PK / PD related topics for the development pipeline
- Manage projects and provide oversight and guidance related to planning, execution, interpretation and reporting of pharmacokinetics (PK) and pharmacodynamics (PD)
- Effectively partner with cross-functional teams as well as external consultants to ensure proper conduct and reporting of clinical trials
- Participate in the preparation of reports/abstracts/manuscripts and regulatory documents
- Work with regulatory agencies through written responses or face-to-face meetings, and participate in drafting responses to regulatory questions
Skills And Requirements
- Post-graduate advanced degree in clinical pharmacology, pharmaceutical sciences, pharmacometrics, or equivalent with a minimum of 10 years of relevant experience related to PK/PD, experience with large molecules will be an asset
- Ability to summarize, communicate and present outcomes of PK/PD analyses into information that can be used by project teams and other stakeholders
- Strong understanding of the basic principles of PK/PD
- Understanding/ with modelling and simulation software and applications such as NONMEM®, PHOENIX® and ADAPT®.
- Thorough experience with relevant regulatory guidelines and track record of MAA/BLA/NDA submissions
- Attention to detail, ability to work under deadline pressure
To apply please send me your CV to email@example.com