Lead, Quantitative Clinical Pharmacology & Strategy

Sarepta Therapeutics; Cambridge (MA); 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 clinical pharmacology and pharmacometrics from early development through product registration, with emphasis on dose selection and predictive PK/PD modeling.

The successful candidate will drive model-based analyses, regulatory strategies, and cross-functional collaboration, and will have a PhD with 7+ years in clinical pharmacology or pharmacometrics; experience with NONMEM and R is highly

Qualifications

• 7+ years of experience in clinical pharmacology or pharmacometrics.
• Strong understanding of clinical pharmacology principles and PK/PD modeling.
• Experience with regulatory interactions is preferred.

Responsibilities

• Lead clinical pharmacology deliverables across drug development and regulatory submissions.
• Drive dose selection/refinement and predictive PK/PD modeling.
• Oversee model-based analyses including population PK/PD and simulations.
• Collaborate with cross-functional teams and regulatory affairs; publish findings.

Skills

Clinical pharmacology

PK/PD modeling

Population PK

Regulatory interactions

Communication

Education

PhD in Pharmaceutical Sciences, mathematics/engineering or related field

Tools

NONMEM

R

Job description

Sarepta Therapeutics in the United States seeks a Director of Quantitative & Clinical Pharmacology to lead clinical pharmacology and pharmacometrics from early development through product registration, with emphasis on dose selection and predictive PK/PD modeling.

The successful candidate will drive model-based analyses, regulatory strategies, and cross-functional collaboration, and will have a PhD with 7+ years in clinical pharmacology or pharmacometrics; experience with NONMEM and R is highly