The PositionArrowhead Pharmaceuticals is seeking a Director of Pharmacometrics and Clinical Pharmacology to provide strategic and scientific leadership across the company's clinical development programs. This senior-level role is responsible for advancing pharmacometric and clinical pharmacology strategies to support the global development and regulatory submission of Arrowhead's leading siRNA therapeutics.
The Director will play a critical role in clinical trial design, data analysis, regulatory documentation, and cross-functional decision-making, ensuring that dosing strategies and clinical pharmacology plans are scientifically rigorous and aligned with regulatory expectations.
Responsibilities
• Provide leadership and subject matter expertise in pharmacometrics and clinical pharmacology across Arrowhead's development portfolio. • Contribute to global regulatory submissions, including marketing applications for siRNA-based therapeutics. • Design and support clinical trial protocols, including dose selection and optimization strategies. • Author and review clinical pharmacology sections of Investigational Brochures (IBs), Clinical Study Reports (CSRs), and other regulatory documents. • Conduct and oversee analysis of clinical and translational PK/PD data, including population PK/PD modeling. • Communicate analysis results, interpretation, and strategic recommendations to project teams in a timely and effective manner. • Develop clinical pharmacology plans and propose dosing strategies across development stages. • Maintain current knowledge of clinical pharmacology literature, regulatory guidance, and best practices relevant to oligonucleotide and RNAi therapeutics.
Requirements
Doctoral degree (PhD, PharmD) in pharmacokinetics, pharmacology, pharmaceutical sciences, or a related discipline.
8 years of post-degree experience in the pharmaceutical or biotechnology industry in pharmacometrics or clinical pharmacology roles.
Demonstrated expertise in population PK/PD modeling, with proficiency in standard software platforms such as NONMEM.
Experience supporting regulatory submissions and interacting with cross-functional development teams.
Preferred Qualifications
Familiarity with PBPK/PD or quantitative systems pharmacology (QSP) modeling.