Director, Pharmacometrics – Clinical Pharmacology

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Act as the lead for pharmacometrics and clinical pharmacology across various development initiatives within Arrowhead’s RNAi therapeutic portfolio.

• Oversee model-informed drug development strategies, which include population PK/PD analyses, exposure-response evaluations, translational modeling, dose optimization, and quantitative interpretation of clinical and translational data.

• Formulate and support clinical pharmacology strategies for first-in-human trials, dose escalation and optimization, proof-of-concept studies, drug-drug interaction assessments, food effect studies, and evaluations for special populations.

• Provide scientific guidance and supervision for PK/PD analyses and modeling efforts carried out both internally and in collaboration with external CRO partners.

• Contribute to global regulatory submissions and interactions with health authorities, including INDs, CTAs, NDA/BLA submissions, briefing documents, and responses to agency inquiries.

• Author and review clinical pharmacology content for Investigational Brochures (IBs), clinical protocols, Clinical Study Reports (CSRs), and regulatory submission documents.

• Work closely with Clinical Development, Translational Sciences, Regulatory Affairs, Biometrics, Biomarkers, Medical Affairs, and Program Leadership teams to support program strategy and execution.

• Present quantitative analyses, development strategies, and recommendations to project teams and senior leadership.

• Stay updated on the latest scientific methodologies, regulatory guidance, and industry trends pertinent to pharmacometrics, clinical pharmacology, and RNAi therapeutics.

⛳️ Requirements

• PhD or an equivalent advanced degree in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences, Biomedical Engineering, Applied Mathematics, or a related quantitative field.

• Over 12 years of experience in pharmacometrics and/or clinical pharmacology, including involvement in late-stage development programs and global regulatory submissions.

• Extensive expertise in population PK/PD modeling and simulation, with strong proficiency in industry-standard software such as NONMEM.

• Solid understanding of exposure-response analysis, translational modeling, dose optimization, and principles of model-informed drug development.

• Experience in supporting regulatory interactions with the FDA, EMA, and other global health authorities.

• Familiarity with PBPK, QSP, mechanistic modeling, or systems pharmacology approaches is highly desirable.

• Previous experience with oligonucleotide, RNAi, rare disease, liver-targeted therapeutics, or other complex biologic modalities is preferred.

• Proven ability to independently manage complex scientific initiatives and influence cross-functional teams in a matrixed environment.

• Outstanding communication and presentation skills, with the capability to convey complex quantitative concepts to both scientific and non-scientific audiences.

• Knowledge of PBPK/PD or quantitative systems pharmacology (QSP) modeling.

🏝️ Benefits

• Competitive salaries

• Excellent benefit package