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