Director, Pharmacometrics & Clinical Pharmacology
Arrowhead Pharmaceuticals
August 11, 2026
Remote friendly (Madison, WI)
United States
Clinical Research and Development
The Position
Director of Pharmacometrics and Clinical Pharmacology
Responsibilities:
- Serve as pharmacometrics and clinical pharmacology lead across multiple RNAi development programs.
- Lead model-informed drug development (population PK/PD, exposure-response, translational modeling, dose optimization, quantitative data interpretation).
- Develop and support clinical pharmacology strategies for first-in-human, dose escalation/optimization, proof-of-concept, DDI, food effect, and special population studies.
- Provide scientific leadership and 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, briefing documents, and agency Q&A).
- 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, strategies, and recommendations to project teams and senior leadership.
- Maintain knowledge of evolving methodologies, regulatory guidance, and industry trends.
Requirements:
- PhD (or equivalent) in PK, 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 population PK/PD modeling and simulation expertise (e.g., NONMEM).
- Strong exposure-response, translational modeling, and model-informed drug development knowledge.
- Experience with regulatory interactions (FDA, EMA, other authorities).
- Excellent communication and ability to explain complex quantitative concepts.
Preferred:
- Familiarity with PBPK/PD and/or QSP modeling.
Benefits:
- Competitive salaries and an excellent benefit package.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.
Director of Pharmacometrics and Clinical Pharmacology
Responsibilities:
- Serve as pharmacometrics and clinical pharmacology lead across multiple RNAi development programs.
- Lead model-informed drug development (population PK/PD, exposure-response, translational modeling, dose optimization, quantitative data interpretation).
- Develop and support clinical pharmacology strategies for first-in-human, dose escalation/optimization, proof-of-concept, DDI, food effect, and special population studies.
- Provide scientific leadership and 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, briefing documents, and agency Q&A).
- 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, strategies, and recommendations to project teams and senior leadership.
- Maintain knowledge of evolving methodologies, regulatory guidance, and industry trends.
Requirements:
- PhD (or equivalent) in PK, 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 population PK/PD modeling and simulation expertise (e.g., NONMEM).
- Strong exposure-response, translational modeling, and model-informed drug development knowledge.
- Experience with regulatory interactions (FDA, EMA, other authorities).
- Excellent communication and ability to explain complex quantitative concepts.
Preferred:
- Familiarity with PBPK/PD and/or QSP modeling.
Benefits:
- Competitive salaries and an excellent benefit package.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.