Director / Senior Director - Clinical Pharmacology Our Client is a precision oncology medicine company looking for a consummate team player seeking a collaborative environment in which to grow their career in drug development.
Responsibilities Oversees activities including non-compartmental PK analysis, population PK, PK/PD, physiologically-based, and other modeling and simulation (M&S) approaches. Coordinates with internal and external team in the data review, analysis and reporting of clinical pharmacology sections of CSRs including PK and pharmacometrics analyses. Author and review clinical protocols, study reports and prepare relevant sections of regulatory documents, including INDs, clinical trial applications (CTAs), Investigator Brochures, regulatory Briefing Documents and NDAs/MAAs. Qualifications An advanced degree and years of experience in the biotech/pharmaceutical industry, with a focus in clinical pharmacology, pharmacokinetics, pharmacometrics or related discipline. Previous experience in managing clinical pharmacology programs, and in the design, execution, and regulatory reporting of clinical PK/PD studies is required. Experience applying M&S through development a plus. Experience conducting clinical pharmacology programs through early and late-stage development. Well versed in authoring and reviewing relevant sections of regulatory dossiers. Proficient in the management of activities at contract research organizations and comfortable working in virtual outsourced model. Please message me to learn more about the company, hiring manager and more! Best regards, TJ Elder 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@01D7D08D.042EA190]<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.
