Global Director, Pharmacometrics & Clinical Pharmacology

Arrowhead Pharmaceuticals, Inc.; San Diego (CA); Sur place; USD 210 000 - 290 000; Plein temps

Résumé du poste

Arrowhead Pharmaceuticals, Inc. is seeking a Director of Pharmacometrics and Clinical Pharmacology to provide strategic leadership across clinical development programs.

This senior role advances pharmacometric and clinical pharmacology strategies to support global development and regulatory submissions for RNAi therapeutics. The Director will influence trial design, data analysis, and regulatory documentation, ensuring dosing strategies are scientifically rigorous and aligned with regulatory

Qualifications

• PhD or equivalent in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline.
• 12+ years in pharmacometrics/clinical pharmacology with late-stage development and regulatory submissions.
• Expertise in population PK/PD modeling and simulation using industry-standard tools.

Responsabilités

• Lead pharmacometrics and clinical pharmacology across multiple programs.
• Design model-informed drug development strategies including PK/PD analyses.
• Support first-in-human studies, dose escalation, and translational modeling.
• Oversee PK/PD analyses and modeling with internal and CRO partners.
• Contribute to regulatory submissions (INDs, NDAs/BLAs) and agency questions.
• Prepare content for IBs, protocols, CSRs, and regulatory submissions.
• Collaborate with cross-functional teams to align program strategy.
• Present quantitative analyses to project teams and leadership.
• Maintain up-to-date knowledge on regulatory guidance and RNAi therapeutics.

Connaissances

Pharmacometrics

PK/PD modeling

Regulatory submissions

Clinical pharmacology

Communication

Formation

PhD in Pharmacokinetics / Pharmacology / Pharmaceutical Sciences

Outils

NONMEM

Description du poste

Arrowhead Pharmaceuticals, Inc. is seeking a Director of Pharmacometrics and Clinical Pharmacology to provide strategic leadership across clinical development programs.

This senior role advances pharmacometric and clinical pharmacology strategies to support global development and regulatory submissions for RNAi therapeutics. The Director will influence trial design, data analysis, and regulatory documentation, ensuring dosing strategies are scientifically rigorous and aligned with regulatory