Director, Pharmacometrics & Clinical Pharmacology

Arrowhead Pharmaceuticals•San Diego, CA

3d•$140,000 - $180,000

About The Position

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Arrowhead 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.

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.

Nice To Haves

Familiarity with PBPK/PD or quantitative systems pharmacology (QSP) modeling

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.