Director, Quantitative Clinical Pharmacology: PK/PD Modeling & Strategy

Sarepta Therapeutics•Carolina, MA

7d•Hybrid

About The Position

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

Requirements

PhD in Pharmaceutical Sciences, mathematics/engineering or related field with 7 years of experience working in clinical pharmacology or pharmacometrics
Strong understanding of clinical pharmacology principles
Strong hands-on experience with PK/PD modeling analysis
Experience in regulatory interactions
Excellent communication, multitasking, and collaboration skills
Candidates must be authorized to work in the U.S.

Nice To Haves

Experience in NONMEM & R highly preferred
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.