Director, Quantitative Clinical Pharmacology & Strategy
Sarepta Therapeutics
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Job summary
The Director of Quantitative & Clinical Pharmacology at Sarepta Therapeutics will lead clinical pharmacology and pharmacometrics deliverables from early through late-stage development, focusing on dose selection, PK/PD modeling, and translational approaches. This highly visible role collaborates across teams to optimize clinical programs.
The ideal candidate holds a PhD in Pharmaceutical Sciences or related field with 7+ years in clinical pharmacology or pharmacometrics, strong PK/PD expertise,
Qualifications
- PhD in Pharmaceutical Sciences, mathematics/engineering or related field with 7 years of experience in clinical pharmacology or pharmacometrics.
- Strong understanding of clinical pharmacology principles, hands-on PK/PD modeling analysis, and experience in regulatory interactions.
- SiRNA and/or CNS experience is preferred.
Responsibilities
- Drives the development and execution of quantitative pharmacology strategies across all stages of drug development through product registration.
- Leads clinical pharmacology expertise in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, study reports.
- Responsible for model-based data analyses including population PK, PK/PD modeling and simulation, meta-analysis, disease modeling to inform clinical development.
- Serves as functional lead for global regulatory strategies and HA engagements.
- Maintains leading-edge knowledge in clinical pharmacology and pharmacometrics, publishes manuscripts and presents at scientific conferences.
Skills
Education
Tools
Job description
The Director of Quantitative & Clinical Pharmacology at Sarepta Therapeutics will lead clinical pharmacology and pharmacometrics deliverables from early through late-stage development, focusing on dose selection, PK/PD modeling, and translational approaches. This highly visible role collaborates across teams to optimize clinical programs.
The ideal candidate holds a PhD in Pharmaceutical Sciences or related field with 7+ years in clinical pharmacology or pharmacometrics, strong PK/PD expertise,
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