Director, Pharmacometrics & Clinical Pharmacology Madison, Wisconsin, United States; Pasadena, [...]

Arrowhead Pharmaceuticals, Inc; San Diego (CA); On-site; USD 200,000 - 225,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefit package

Job summary

A leading biopharmaceutical company in California is looking for a Director of Pharmacometrics and Clinical Pharmacology. This senior-level role involves providing strategic and scientific leadership across clinical development programs. The ideal candidate should hold a doctoral degree and have at least 8 years of experience in pharmacometrics or clinical pharmacology. Responsibilities include overseeing clinical trial designs, regulatory submission support, and maintaining knowledge of clinical pharmacology standards. Competitive salary and benefits package offered.

Qualifications

• 8 years of post-degree experience in pharmacometrics or clinical pharmacology roles.
• Demonstrated expertise in population PK/PD modeling.
• Experience supporting regulatory submissions.

Responsibilities

• Provide leadership in pharmacometrics and clinical pharmacology across development.
• Contribute to global regulatory submissions for siRNA therapeutics.
• Design clinical trial protocols and strategies.

Skills

Leadership in pharmacometrics and clinical pharmacology

Population PK/PD modeling

Regulatory submission experience

Education

Doctoral degree (PhD, PharmD)

Tools

NONMEM

Job description

Director, Pharmacometrics & Clinical Pharmacology

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.

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

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

$200,000 — $225,000 USD

$220,000 — $245,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

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