Director, Pharmacometrics & Clinical Pharmacology
Arrowhead Pharmaceuticals
August 11, 2026
On-site
Los Angeles, CA
Clinical Research and Development
Responsibilities:
- Serve as the pharmacometrics and clinical pharmacology lead across multiple development programs within Arrowhead’s RNAi therapeutic portfolio.
- Lead model-informed drug development (population PK/PD, exposure-response, translational modeling, dose optimization, interpretation of clinical/translational data).
- Develop and support clinical pharmacology strategies for first-in-human studies, dose escalation/optimization, proof-of-concept, DDI, food effect, and special population evaluations.
- Provide scientific leadership/oversight for PK/PD analyses and modeling (internal and via external CROs).
- Contribute to global regulatory submissions and health authority interactions (INDs, CTAs, NDA/BLA submissions, briefing documents, agency question responses).
- Author/review clinical pharmacology content for IBs, clinical protocols, CSRs, and regulatory submissions.
- Collaborate with Clinical Development, Translational Sciences, Regulatory Affairs, Biometrics, Biomarkers, Medical Affairs, and Program Leadership.
- Present quantitative analyses and recommendations to project teams and senior leadership.
- Maintain current knowledge of methodologies, regulatory guidance, and industry trends.
Requirements:
- PhD or equivalent in Pharmacokinetics/Pharmacology/Pharmaceutical Sciences/Biomedical Engineering/Applied Mathematics or related quantitative discipline.
- 12+ years in pharmacometrics and/or clinical pharmacology, including late-stage development and global regulatory submissions.
- Deep population PK/PD modeling/simulation expertise; proficiency with NONMEM.
- Strong exposure-response, translational modeling, and dose optimization knowledge.
- Experience with regulatory interactions (FDA, EMA, other global authorities).
- Ability to independently lead complex initiatives and influence cross-functional teams.
- Excellent communication skills for scientific and non-scientific audiences.
Preferred:
- Familiarity with PBPK/PD or quantitative systems pharmacology (QSP) modeling.
- Knowledge/experience with PBPK, QSP, mechanistic, or systems pharmacology; prior experience with oligonucleotide/RNAi/rare disease/liver-targeted or other complex biologic modalities.
Benefits:
- Competitive salaries and an excellent benefit package.
- Wisconsin pay range: $200,000–$230,000; California pay range: $230,000–$255,000.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.
- Serve as the pharmacometrics and clinical pharmacology lead across multiple development programs within Arrowhead’s RNAi therapeutic portfolio.
- Lead model-informed drug development (population PK/PD, exposure-response, translational modeling, dose optimization, interpretation of clinical/translational data).
- Develop and support clinical pharmacology strategies for first-in-human studies, dose escalation/optimization, proof-of-concept, DDI, food effect, and special population evaluations.
- Provide scientific leadership/oversight for PK/PD analyses and modeling (internal and via external CROs).
- Contribute to global regulatory submissions and health authority interactions (INDs, CTAs, NDA/BLA submissions, briefing documents, agency question responses).
- Author/review clinical pharmacology content for IBs, clinical protocols, CSRs, and regulatory submissions.
- Collaborate with Clinical Development, Translational Sciences, Regulatory Affairs, Biometrics, Biomarkers, Medical Affairs, and Program Leadership.
- Present quantitative analyses and recommendations to project teams and senior leadership.
- Maintain current knowledge of methodologies, regulatory guidance, and industry trends.
Requirements:
- PhD or equivalent in Pharmacokinetics/Pharmacology/Pharmaceutical Sciences/Biomedical Engineering/Applied Mathematics or related quantitative discipline.
- 12+ years in pharmacometrics and/or clinical pharmacology, including late-stage development and global regulatory submissions.
- Deep population PK/PD modeling/simulation expertise; proficiency with NONMEM.
- Strong exposure-response, translational modeling, and dose optimization knowledge.
- Experience with regulatory interactions (FDA, EMA, other global authorities).
- Ability to independently lead complex initiatives and influence cross-functional teams.
- Excellent communication skills for scientific and non-scientific audiences.
Preferred:
- Familiarity with PBPK/PD or quantitative systems pharmacology (QSP) modeling.
- Knowledge/experience with PBPK, QSP, mechanistic, or systems pharmacology; prior experience with oligonucleotide/RNAi/rare disease/liver-targeted or other complex biologic modalities.
Benefits:
- Competitive salaries and an excellent benefit package.
- Wisconsin pay range: $200,000–$230,000; California pay range: $230,000–$255,000.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.