Director, Pharmacometrics & Clinical Pharmacology
Arrowhead Pharmaceuticals
August 11, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
The Position:
Director of Pharmacometrics and Clinical Pharmacology to provide strategic and scientific leadership across clinical development programs, advancing pharmacometric and clinical pharmacology strategies to support global development and regulatory submission of siRNA therapeutics.
Responsibilities:
- Serve as the pharmacometrics and clinical pharmacology lead across multiple development programs.
- Lead model-informed drug development strategies (population PK/PD analyses, exposure-response analyses, translational modeling, dose optimization, and quantitative interpretation of clinical/translational data).
- Develop and support clinical pharmacology strategies for first-in-human, dose escalation/optimization, proof-of-concept, drug-drug interactions, food effects, and special population evaluations.
- Provide scientific leadership and oversight for PK/PD analyses and modeling (internally and via external CROs).
- Contribute to global regulatory submissions and health authority interactions (INDs, CTAs, NDA/BLA submissions, briefing documents, and responses to agency questions).
- Author/review clinical pharmacology content for IBs, clinical protocols, CSRs, and regulatory submission documents.
- 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 knowledge of evolving 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 (late-stage and global regulatory submission experience).
- Deep expertise in population PK/PD modeling and simulation; proficiency in NONMEM.
- Strong knowledge of exposure-response, translational modeling, dose optimization, and model-informed drug development.
- Experience with regulatory interactions (FDA, EMA, and other authorities).
- Knowledge of PBPK, QSP, mechanistic modeling, or systems pharmacology (highly desirable).
- Preferred: experience with oligonucleotide/RNAi, rare disease, liver-targeted therapeutics, or other complex biologics.
- Ability to independently lead complex scientific initiatives and influence cross-functional teams.
- Excellent communication/presentation skills.
Preferred:
- Familiarity with PBPK/PD or QSP modeling.
Benefits/Compensation:
- Wisconsin pay range: $200,000–$230,000. California pay range: $230,000–$255,000.
- Competitive salaries and excellent benefit package.
Application instructions:
- Candidates must have current, valid authorization to work in the country where the role is located.
Director of Pharmacometrics and Clinical Pharmacology to provide strategic and scientific leadership across clinical development programs, advancing pharmacometric and clinical pharmacology strategies to support global development and regulatory submission of siRNA therapeutics.
Responsibilities:
- Serve as the pharmacometrics and clinical pharmacology lead across multiple development programs.
- Lead model-informed drug development strategies (population PK/PD analyses, exposure-response analyses, translational modeling, dose optimization, and quantitative interpretation of clinical/translational data).
- Develop and support clinical pharmacology strategies for first-in-human, dose escalation/optimization, proof-of-concept, drug-drug interactions, food effects, and special population evaluations.
- Provide scientific leadership and oversight for PK/PD analyses and modeling (internally and via external CROs).
- Contribute to global regulatory submissions and health authority interactions (INDs, CTAs, NDA/BLA submissions, briefing documents, and responses to agency questions).
- Author/review clinical pharmacology content for IBs, clinical protocols, CSRs, and regulatory submission documents.
- 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 knowledge of evolving 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 (late-stage and global regulatory submission experience).
- Deep expertise in population PK/PD modeling and simulation; proficiency in NONMEM.
- Strong knowledge of exposure-response, translational modeling, dose optimization, and model-informed drug development.
- Experience with regulatory interactions (FDA, EMA, and other authorities).
- Knowledge of PBPK, QSP, mechanistic modeling, or systems pharmacology (highly desirable).
- Preferred: experience with oligonucleotide/RNAi, rare disease, liver-targeted therapeutics, or other complex biologics.
- Ability to independently lead complex scientific initiatives and influence cross-functional teams.
- Excellent communication/presentation skills.
Preferred:
- Familiarity with PBPK/PD or QSP modeling.
Benefits/Compensation:
- Wisconsin pay range: $200,000–$230,000. California pay range: $230,000–$255,000.
- Competitive salaries and excellent benefit package.
Application instructions:
- Candidates must have current, valid authorization to work in the country where the role is located.