Director, Pharmacometrics – Clinical Pharmacology

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🕒 Yesterday

🏄 California, Wisconsin – Remote

🏄 California – Remote 🧀 Wisconsin – Remote

💵 $190k - $255k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 0%

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Arrowhead Pharmaceuticals

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Arrowhead Pharmaceuticals is a biotechnology company that develops RNA interference (RNAi)-based therapeutics to silence disease-causing genes and treat intractable, often intractable, cardiometabolic and pulmonary disorders. Using a portfolio of RNA chemistries and delivery technologies, Arrowhead aims to induce rapid, deep, and durable knockdown of target genes to address conditions such as hypertriglyceridemia, dyslipidemia, cardiovascular disease, and various pulmonary diseases.

📋 Description

• Serve as the pharmacometrics and clinical pharmacology lead across multiple development programs within Arrowhead’s RNAi therapeutic portfolio. • Lead model-informed drug development strategies, including population PK/PD analyses, exposure-response analyses, translational modeling, dose optimization, and quantitative interpretation of clinical and translational data. • Develop and support clinical pharmacology strategies for first-in-human studies, dose escalation and optimization, proof-of-concept studies, drug-drug interaction assessments, food effect studies, and special population evaluations. • Provide scientific leadership and oversight for PK/PD analyses and modeling activities conducted internally and through external CRO partners. • Contribute to global regulatory submissions and health authority interactions, including INDs, CTAs, NDA/BLA submissions, briefing documents, and responses to agency questions. • Author and review clinical pharmacology content for Investigational Brochures (IBs), clinical protocols, Clinical Study Reports (CSRs), and regulatory submission documents. • Collaborate 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. • Maintain current knowledge of evolving scientific methodologies, regulatory guidance, and industry trends related to pharmacometrics, clinical pharmacology, and RNAi therapeutics.

🎯 Requirements

• PhD or equivalent advanced degree in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences, Biomedical Engineering, Applied Mathematics, or related quantitative discipline. • 12+ years in pharmacometrics and/or clinical pharmacology, including experience supporting late-stage development programs and global regulatory submissions. • Deep expertise in population PK/PD modeling and simulation with strong proficiency in industry-standard software such as NONMEM. • Strong understanding of exposure-response analysis, translational modeling, dose optimization, and model-informed drug development principles. • Experience supporting regulatory interactions with FDA, EMA, and other global health authorities. • Knowledge of PBPK, QSP, mechanistic modeling, or systems pharmacology approaches is highly desirable. • Prior experience with oligonucleotide, RNAi, rare disease, liver-targeted therapeutics, or other complex biologic modalities is preferred. • Demonstrated ability to independently lead complex scientific initiatives and influence cross-functional teams in a matrixed environment. • Excellent communication and presentation skills, with the ability to clearly communicate complex quantitative concepts to scientific and non-scientific audiences. • Familiarity with PBPK/PD or quantitative systems pharmacology (QSP) modeling.

🏖️ Benefits

• Competitive salaries • Excellent benefit package

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