Director, Quantitative PK/PD Strategy & Translation

Sarepta Therapeutics; Newark (NJ); Hybrid; USD 186,000 - 232,000; Full time

Benefits offered by this job

Hybrid work model

Competitive compensation and benefits

Equal Opportunity/Affirmative Action;

Job summary

Sarepta Therapeutics seeks a Director of Quantitative & Clinical Pharmacology to lead clinical pharmacology and pharmacometrics deliverables from early to late-stage development, with emphasis on dose selection and PK/PD modeling. This highly visible role requires strategic leadership and collaboration with multidisciplinary teams.

The candidate will guide regulatory interactions, model-based analyses, and translational approaches, driving data-driven decisions across Duchenne/other programs,

Qualifications

• PhD required in Pharmaceutical Sciences, mathematics/engineering or related field.
• 7+ years of experience in clinical pharmacology or pharmacometrics.
• Strong understanding of clinical pharmacology principles and PK/PD modeling.

Responsibilities

• Lead clinical pharmacology and pharmacometrics deliverables across drug development stages through registration.
• Provide protocol preparation, study execution, data review/analysis, and study reports.
• Serve as functional lead for global regulatory strategies and HA engagements.
• Maintain cutting-edge knowledge; publish and present at conferences.

Skills

Clinical pharmacology principles

PK/PD modeling

Regulatory interactions

Communication

NONMEM

R

CNS experience

Education

PhD in Pharmaceutical Sciences, mathematics/engineering or related field

Tools

NONMEM

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Job description

Sarepta Therapeutics seeks a Director of Quantitative & Clinical Pharmacology to lead clinical pharmacology and pharmacometrics deliverables from early to late-stage development, with emphasis on dose selection and PK/PD modeling. This highly visible role requires strategic leadership and collaboration with multidisciplinary teams.

The candidate will guide regulatory interactions, model-based analyses, and translational approaches, driving data-driven decisions across Duchenne/other programs,