Senior Director, Quantitative & Clinical Pharmacology
Sarepta Therapeutics
July 03, 2026
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
The Importance of the Role
This leadership role will develop and execute translational, clinical pharmacology, and pharmacometrics strategies and deliverables from early through late-stage clinical development. Manage a team of scientists and serve as a SME on programs.
Responsibilities
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred)
- Serve as therapeutic lead (siRNA/oligonucleotide experience preferred) and SME for clinical pharmacology strategies, protocol preparation, study execution, data review/analysis, and study reports
- Lead translational, mechanistically based PK/PD modeling to enable FIH dose selection and early efficacy/safety characterization using biomarkers and disease animal models
- Lead pharmacometrics strategies across all stages (population PK, PK/PD modeling and simulations, meta-analysis, disease modeling)
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy, study design/execution, analyses to inform lead optimization and candidate selection)
- Lead global regulatory activities and Health Authority engagements (NDA and/or BLA experience required)
- Supervise, mentor, and develop scientists
- Contribute to platform-based pharmacology activities across genetic modalities and disease indications
- Publish manuscripts and advocate scientific leadership at external conferences
Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field with ≥10 years biotech/pharma experience
- Expertise in clinical pharmacology/pharmacometrics; hands-on modeling and data analytics; regulatory success from IND through registration
- siRNA and/or oligonucleotide experience highly preferred
- Proven success leading high-performing teams and developing people
- Excellent communication, multitasking, and collaboration in cross-functional/matrixed environments
Application/Work Details
- Hybrid role; work on-site in the U.S. and/or attend in-person events from time to time.
This leadership role will develop and execute translational, clinical pharmacology, and pharmacometrics strategies and deliverables from early through late-stage clinical development. Manage a team of scientists and serve as a SME on programs.
Responsibilities
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred)
- Serve as therapeutic lead (siRNA/oligonucleotide experience preferred) and SME for clinical pharmacology strategies, protocol preparation, study execution, data review/analysis, and study reports
- Lead translational, mechanistically based PK/PD modeling to enable FIH dose selection and early efficacy/safety characterization using biomarkers and disease animal models
- Lead pharmacometrics strategies across all stages (population PK, PK/PD modeling and simulations, meta-analysis, disease modeling)
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy, study design/execution, analyses to inform lead optimization and candidate selection)
- Lead global regulatory activities and Health Authority engagements (NDA and/or BLA experience required)
- Supervise, mentor, and develop scientists
- Contribute to platform-based pharmacology activities across genetic modalities and disease indications
- Publish manuscripts and advocate scientific leadership at external conferences
Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field with ≥10 years biotech/pharma experience
- Expertise in clinical pharmacology/pharmacometrics; hands-on modeling and data analytics; regulatory success from IND through registration
- siRNA and/or oligonucleotide experience highly preferred
- Proven success leading high-performing teams and developing people
- Excellent communication, multitasking, and collaboration in cross-functional/matrixed environments
Application/Work Details
- Hybrid role; work on-site in the U.S. and/or attend in-person events from time to time.