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
- 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.
Requirements- 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.
Preferred
- Familiarity with PBPK/PD or quantitative systems pharmacology (QSP) modeling
Wisconsin pay range
$200,000-$230,000 USD
California pay range
$230,000-$255,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
