Director, Quantitative Pharmacology & Translational Science

Sarepta Therapeutics; New York (NY); Hybrid; USD 186,000 - 232,000; Full time

Job summary

Sarepta Therapeutics in the United States seeks a Director of Quantitative & Clinical Pharmacology to lead dose selection, PK/PD modeling, and pharmacometrics across early to late-stage development, including regulatory interactions.

You will head global clinical pharmacology strategies, collaborate across teams, and stay at the forefront of model-based analyses, population PK, and translational approaches while shaping drug development for Duchenne and related programs.

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, and experience in regulatory interactions.
• Excellent communication, multitasking and collaboration skills.
• siRNA and/or CNS experience is preferred.

Responsibilities

• Drives the development and execution of the 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 discipline, publishes manuscripts, presents at scientific conferences and scientific forums.

Skills

PK/PD modeling

Population PK

Regulatory interactions

NONMEM

R

Clinical pharmacology

Education

PhD in Pharmaceutical Sciences

Tools

NONMEM

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Job description

Sarepta Therapeutics in the United States seeks a Director of Quantitative & Clinical Pharmacology to lead dose selection, PK/PD modeling, and pharmacometrics across early to late-stage development, including regulatory interactions.

You will head global clinical pharmacology strategies, collaborate across teams, and stay at the forefront of model-based analyses, population PK, and translational approaches while shaping drug development for Duchenne and related programs.