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Director, Pharmacometrics – Clinical Pharmacology
Arrowhead Pharmaceuticals. Serve as the pharmacometrics and clinical pharmacology lead across multiple development programs within Arrowhead’s RNAi therapeutic portfolio.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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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Tip: use these terms in your resume and cover letter to boost ATS matches.
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