Director of Pharmacometrics & Clinical Pharmacology

Arrowhead Pharmaceuticals, Inc.; Madison (WI); On-site; USD 180,000 - 300,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a Director of Pharmacometrics and Clinical Pharmacology to provide strategic leadership across clinical development programs for RNAi therapeutics.

You will lead model-informed drug development, oversee PK/PD analyses, contribute to regulatory submissions, and collaborate with cross-functional teams to ensure scientifically rigorous dosing strategies and pharmacology plans aligned with regulatory expectations.

Qualifications

• PhD or equivalent required in Pharmacokinetics, Pharmacology, or related field.
• 12+ years in pharmacometrics/clinical pharmacology with late-stage development.
• Expertise in population PK/PD modeling and NONMEM.
• Experience with FDA/EMA regulatory interactions.
• Knowledge of PBPK, QSP, or systems pharmacology is desirable.
• Experience with oligonucleotide/RNAi modalities preferred.

Responsibilities

• Lead pharmacometrics and clinical pharmacology across programs.
• Lead model-informed drug development and exposure-response analyses.
• Develop strategies for first-in-human studies and dose optimization.
• Provide oversight for PK/PD analyses and external CROs.
• Support regulatory submissions and health authority interactions.
• Author content for IBs, protocols, CSRs, and submissions.
• Collaborate with cross-functional teams to align strategy.
• Present analyses and recommendations to leadership.
• Stay current with regulatory guidance and RNAi pharmacology.

Skills

Pharmacometric leadership

Clinical pharmacology

Population PK/PD modeling

Model-informed development

Regulatory submissions

Data analysis

Education

PhD or equivalent in Pharmacokinetics/Pharmacology/Pharmaceutical Sciences

Tools

NONMEM

Job description

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a Director of Pharmacometrics and Clinical Pharmacology to provide strategic leadership across clinical development programs for RNAi therapeutics.

You will lead model-informed drug development, oversee PK/PD analyses, contribute to regulatory submissions, and collaborate with cross-functional teams to ensure scientifically rigorous dosing strategies and pharmacology plans aligned with regulatory expectations.