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

About the role

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.

Responsibilities

• Lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Phase 3 and product registration), with 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.
• Drive the development and execution of quantitative pharmacology strategies across all stages of drug development through product registration.
• Lead 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.
• Serve as functional lead for global regulatory strategies and health authority engagements.
• Maintain leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publish manuscripts, present 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.
• Excellent communication, multitasking, and collaboration skills.
• Experience in NONMEM & R highly preferred.
• siRNA and/or CNS experience preferred.
• Candidates must be authorized to work in the U.S.

Benefits

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

Pay

The targeted salary range for this position is $185,600 - $232,000 per year.

Schedule

This position is hybrid; you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.