Director, Quantitative Clinical Pharmacology: PK/PD Modeling & Strategy
Why Sarepta? Why Now? 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.
About the role
The Director of Quantitative & Clinical Pharmacology will be responsible to lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Ph3 and product registration), with an emphasis on clinical dose selection/refinement and predictive PK/PD modeling inclusive of population and statistically-based methodologies, as well as mechanistic and translational-focused approaches. This is a highly visible and team-facing role.
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
Requirements
- PhD in Pharmaceutical Sciences, mathematics/engineering or related field
- 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
- Candidates must be authorized to work in the U.S.
Skills
- Excellent communication, multitasking, and collaboration skills
- Experience in NONMEM & R highly preferred
- siRNA and/or CNS experience is preferred
Benefits
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers