Please message me to learn more about this (new!) role at a growing company with a robust pipeline (over 10 assets!)
Responsibilities * Lead clinical pharmacology programs, serve as subject matter expert to the team * Design PK, immunogenicity, biomarker and pharmacodynamic components of protocols * Execute the analysis of data, including PK/PD data analysis and modeling and simulation, write reports. * Interpret, summarize, and present data to project teams, senior management, and external partners/organizations, conferences * Contribute to clinical pharmacology strategy and planning for clinical programs * Ensure timely and accurate communication of study results and interpretation with appropriate internal drug development teams * Ensure high quality of documentation compatible with global regulatory submission requirements * Maintain a current understanding of small and large molecule PK/pharmacometrics literature and methodology including RNAi therapeutics, and the state-of-art in Model-Informed Drug Development (MIDD) Requirements: * PhD (or work-place equivalent) in pharmacokinetics, pharmacology or pharmaceutical science * Industrial experience in PopPK, PK/PD modeling and data reporting using NONMEM, Phoenix WinNonlin or some other similar program with familiarity of authorizing PK clinical study report (PK CSR) in submission standard * Knowledge of FDA/ICH guidance related to NCA, PopPK, PK/PD modeling analysis is required Preferred: * Industry experience in clinical-stage drug development is preferred * Skills in population PK, PK/PD modeling using NONMEM or NLME is desired, while PBPK modeling experience is a plus TJ Elder President Pre-Clinical Development O: 413.458.6124 C: 413.207.7676 https://www.linkedin.com/in/tjelder/ tel...@stem-sourcing.com<mailto:tel...@stem-sourcing.com> [cid:image001.png@01D99D1C.E4B802D0]<http://www.stem-sourcing.com/> Please Note: The information in this e-mail message is legally privileged and confidential information intended only for the use of the addressee(s) named above. If you, the reader of this message, are not the intended recipient, you are hereby notified that you should not further disseminate, distribute, or forward this e-mail message. If you have received this e-mail in error, please notify the sender as soon as possible. In addition, please delete the erroneously received message from any device/media where the message is stored.
