Senior Clinical Pharmacology Strategist: Modeling & Simulation

ISoP; Princeton (NJ); Hybrid; USD 150,000 - 200,000; Full time

Job summary

ISoP, a clinical-stage biopharmaceutical company, is seeking a Senior Manager or Associate Director of Clinical Pharmacology in a hybrid Princeton, NJ setting. The role focuses on strategy, quantitative analyses, dose optimization, and modeling to advance clinical programs.

You will collaborate with Clinical Development, Research, Regulatory, Biometrics, and other teams to drive development decisions and ensure robust pharmacology support for regulatory submissions.

Qualifications

• MS/PhD/PharmD in Pharmacology, Pharmaceutical Sciences, or related field
• Experience in clinical pharmacology and pharmacometrics with hands-on quantitative analyses
• Strong understanding of PK/PD, exposure–response, and clinical drug development

Responsibilities

• Develop and execute clinical pharmacology strategies across programs
• Support dose selection and dosing schedules, including DDIs
• Conduct and interpret PK/PD, population PK, and exposure–response analyses
• Apply modeling and simulation to support development decisions
• Contribute to design and execution of clinical pharmacology studies (FIH, pOC, registrational)
• Prepare pharmacology sections of protocols, CSRs, IBs, and submissions
• Support responses to regulatory questions with cross-functional teams

Skills

Clinical pharmacology

Pharmacometrics

PK/PD

Modeling & simulation

Cross-functional collaboration

Education

MS/PhD/PharmD in a related field

Tools

NONMEM

R

Phoenix WinNonlin

Simcyp

Job description

ISoP, a clinical-stage biopharmaceutical company, is seeking a Senior Manager or Associate Director of Clinical Pharmacology in a hybrid Princeton, NJ setting. The role focuses on strategy, quantitative analyses, dose optimization, and modeling to advance clinical programs.

You will collaborate with Clinical Development, Research, Regulatory, Biometrics, and other teams to drive development decisions and ensure robust pharmacology support for regulatory submissions.