Hello All!
Our Client is seeking an experienced leader in Clinical Pharmacology &
Pharmacometrics. The role will be primarily Clin Pharm analyzing and
interpreting models developed by the in-house PMx team. This role will not
involve hands on modeling. The ideal candidate will bring deep expertise in
Clinical Pharmacology and a strong track record in drug development. You will
lead clinical pharmacology and pharmacometric strategies from IND through Phase
IV, fostering cross-functional collaboration with teams across pharmacology,
biomarkers, DMPK, clinical development, regulatory, CMC, and medical affairs.
This role will report to VP of Clinical Pharmacology and Pharmacometrics.
Key Responsibilities
* Develop and execute CPP strategies across all clinical stages (Phase
I-III) and indications.
* Guide data interpretation from pharmacometric analyses (PPK,
exposure-response, etc.) and recommend dosing strategies for clinical trials.
* Collaborate with biologists, preclinical scientists, biostatisticians,
and clinical teams to support development programs.
* Author and review NCA PK, population PK, and exposure-response reports;
contribute to regulatory documents (e.g., sNDA/sBLA, EOP2 packages).
* Present findings to program teams, senior leadership, and external
collaborators.
* May lead and mentor a team of clinical pharmacologists.
* Contribute to organizational goals in CPP and translational medicine.
* Stay current on scientific and regulatory advancements; publish in
peer-reviewed journals.
Qualifications
* Ph.D. or M.D. with years of relevant experience.
* Proven success in regulatory interactions (INDs, EOP1/2, RTOR, AA,
approvals).
* Strong leadership in managing scientific and quantitative teams.
* Excellent communication and cross-functional collaboration skills.
* Preferred experience with pharmacometric tools (NONMEM, R, SimCYP,
GastroPlus).
* Ability to meet timelines and work effectively in a matrix environment.
* Demonstrated publication record in top-tier scientific journals.
I look forward to connecting!
TJ Elder
President
Clinical Pharmacology / Pharmacometrics
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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