California based Director or Senior Director of Pharmacometrics and Clin Pharm opportunity

1 messages 1 people Latest: May 22, 2024
Hello Again! Our Client is seeking a highly skilled and experienced Senior Director of Pharmacometrics and Clinical Pharmacology to lead their efforts in early and late-stage clinical drug development (Phase 1-3). The successful candidate will be responsible for designing and implementing pharmacometric and clinical pharmacology strategies that ensure the successful development of innovative therapeutics. Develop and execute comprehensive pharmacometrics and clinical pharmacology strategies for Phase 1-3 clinical trials. Oversee the design, execution, and analysis of clinical pharmacology studies, including first-in-human (FIH), dose escalation, bioavailability, bioequivalence, and drug-drug interaction studies. Ensure timely and accurate interpretation of PK/PD data and its integration into clinical development plans. Lead the preparation of clinical pharmacology sections of regulatory submissions (INDs, NDAs, BLAs) and represent the company in regulatory interactions. Lead and mentor a team of pharmacometricians and clinical pharmacologists, fostering a collaborative and innovative work environment. Proven track record of leading pharmacometrics and clinical pharmacology efforts in the development of novel therapeutics, with successful regulatory submissions. Please message me to learn more. Thank you as always! TJ TJ Elder President Pre-Clinical Development O: 413.458.6124 C: 413.207.7676 https://www.linkedin.com/in/tjelder/ [email protected]<mailto:[email protected]> [cid:[email 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.