Senior Scientist / Principal Scientist, Clinical Pharmacology

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing 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 (RNAi) mechanism to induce rapid, deep, and durable knockdown of target genes. The company focuses on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins involved in disease. Arrowhead’s RNAi technologies enable addressing conditions across virtually any therapeutic area, including disease targets not otherwise addressable by small molecules and biologics. The company leads the field in bringing RNAi therapies to diseases outside the liver, with a clinical pipeline targeting the liver and lung, and a robust preclinical pipeline. Headquartered in Pasadena, CA, Arrowhead has research and development teams in Madison, WI, and San Diego, CA, and a state-of-the-art manufacturing facility in Verona, WI.

About the role

This role provides clinical pharmacology and pharmacometrics leadership for assigned development programs and may be based in San Diego, CA, or Madison, WI. The position contributes to clinical trial design, authors key protocol and regulatory sections, and performs hands-on PK/PD analyses to guide dose selection and program strategy. It oversees the preparation and authorization of PK analysis reports, clinical study report (CSR) content, and clinical pharmacology components of global regulatory submissions.

Responsibilities

• Provide clinical pharmacology and pharmacometrics leadership for designated programs, contributing to the design of clinical trial protocols and relevant sections in the Investigational Brochure (IB).
• Conduct hands-on analysis of clinical or translational PK/PD data to support dosing strategies and clinical pharmacology planning.
• Authorize clinical PK analysis reports and relevant sections in the Clinical Study Report (CSR).
• Provide high-quality documentation of clinical pharmacology analysis compatible with global regulatory submission requirements.
• Authorize clinical pharmacology modules of the Common Technical Document (CTD) to support global filings of marketing applications.
• Communicate analysis results and interpretations with drug development teams in a timely manner.
• Maintain a current understanding of clinical pharmacology literature and regulatory guidance for oligonucleotide/RNAi therapeutics.

Requirements

• PhD or PharmD in pharmacokinetics, pharmacology, or pharmaceutical science.
• 3+ years of pharmaceutical industry experience in clinical-stage drug development.
• Good understanding of FDA/EMA/ICH guidance related to clinical pharmacology.
• Established experience in clinical NCA PK analysis and data reporting using Phoenix WinNonlin, including authoring PK study reports.
• Proficiency in NONMEM and population PK/PD modeling.

Preferred Qualifications

• Experience with PBPK/PD modeling.

Pay

California pay range: $120,000–$170,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.