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Arrowhead Pharmaceuticals

Director, Pharmacometrics – Clinical Pharmacology

Arrowhead Pharmaceuticals

. Serve as the pharmacometrics and clinical pharmacology lead across multiple development programs within Arrowhead’s RNAi therapeutic portfolio.

Posted 10/30/2026full-timeRemote • United StatesLead💰 $190,000 - $255,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in pharmacometrics and clinical pharmacology, with a strong focus on population PK/PD modeling, regulatory submissions, and cross-functional collaboration. Proven ability to lead complex scientific initiatives and communicate quantitative analyses effectively to diverse audiences.

Highest-signal resume keywords
Pharmacokinetics ExpertisePopulation PK/PD ModelingRegulatory Submission ExperienceNONMEM ProficiencyClinical Pharmacology Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Population PK/PD AnalysisExposure-Response AnalysisTranslational ModelingDose OptimizationModel-Informed Drug DevelopmentQuantitative InterpretationDrug-Drug Interaction AssessmentFood Effect StudiesSpecial Population EvaluationsClinical Study Report Authoring
Soft Skills
Excellent Communication SkillsPresentation SkillsLeadership AbilityInfluencing Cross-Functional Teams
Tools & Technologies
NONMEMPBPK ModelingQSP ModelingClinical ProtocolsInvestigational Brochures
Certifications & Qualifications
PhD in PharmacokineticsPhD in PharmacologyPhD in Pharmaceutical SciencesPhD in Biomedical EngineeringPhD in Applied Mathematics
Industry Keywords
RNAi TherapeuticsOligonucleotide TherapeuticsRare DiseaseLiver-Targeted TherapeuticsGlobal Regulatory SubmissionsFDA InteractionsEMA InteractionsClinical DevelopmentTranslational SciencesBiometrics

About the role

Key responsibilities & impact
  • 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

What you’ll need
  • 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.
  • Familiarity with PBPK/PD or quantitative systems pharmacology (QSP) modeling.

Benefits

Comp & perks
  • Competitive salaries
  • Excellent benefit package