Director, Pharmacometrics – Clinical Pharmacology

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🕒 Outubro 30

🏄 California, Wisconsin – Remoto

🏄 California – Remote 🧀 Wisconsin – Remote

💵 $190.000 - $255.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Arrowhead Pharmaceuticals

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

A Arrowhead Pharmaceuticals é uma empresa de biotecnologia que desenvolve terapias baseadas em interferência de RNA (RNAi) para silenciar genes causadores de doenças e tratar distúrbios cardiometabólicos e pulmonares frequentemente intratáveis. Utilizando um portfólio de químicas de RNA e tecnologias de entrega, a Arrowhead visa induzir a redução rápida, profunda e duradoura de genes-alvo para tratar condições como hipertrigliceridemia, dislipidemia, doenças cardiovasculares e diversas doenças pulmonares.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• Competitive salaries • Excellent benefit package

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