Senior Director, Quantitative & Clinical Pharmacology
Sarepta Therapeutics
5 months ago
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
The Importance of the Role
- Develop and execute translational, clinical pharmacology and pharmacometrics strategies and deliverables from early through late-stage clinical development.
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred).
- Serve as therapeutic lead and SME in clinical pharmacology strategies, including clinical protocol preparation, study execution, data review/analysis, and study reports.
- Develop and execute translational, mechanistically based PK/PD modeling to enable identification of FIH dose and early characterization of efficacy and safety using biomarkers and disease animal models.
- Lead and execute pharmacometrics strategies across all stages of drug development (population PK, PK/PD modeling and simulations, meta-analysis, disease modeling to inform clinical development).
- Support non-clinical PK/PD, ADME and DMPK evaluations (strategy development, study design/execution, data analyses to inform lead optimization and candidate selection).
- Represent as functional lead for global regulatory activities and Health Authority engagements (NDA and/or BLA experience is a must).
- Supervise, mentor, and develop a team of high-performing scientists.
- Contribute to platform-based pharmacology activities across novel genetic modalities and disease indications.
- Publish manuscripts and advocate scientific leadership at external conferences.
More About You / Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences or related field + ≥10 years’ biotech/pharma experience.
- Expertise in clinical pharmacology and pharmacometrics principles; strong hands-on modeling and data analytics; proven regulatory success from IND through registration.
- siRNA and/or oligonucleotide experience highly preferred.
- Demonstrated success leading/building high-performing teams.
- Excellent communication, multitasking, and collaboration in cross-functional/matrix environments.
Benefits (explicitly stated)
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application instructions / Other
- Hybrid role: expected to work on-site in the U.S. and/or attend in-person events occasionally.
- Candidates must be authorized to work in the U.S.
- Develop and execute translational, clinical pharmacology and pharmacometrics strategies and deliverables from early through late-stage clinical development.
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred).
- Serve as therapeutic lead and SME in clinical pharmacology strategies, including clinical protocol preparation, study execution, data review/analysis, and study reports.
- Develop and execute translational, mechanistically based PK/PD modeling to enable identification of FIH dose and early characterization of efficacy and safety using biomarkers and disease animal models.
- Lead and execute pharmacometrics strategies across all stages of drug development (population PK, PK/PD modeling and simulations, meta-analysis, disease modeling to inform clinical development).
- Support non-clinical PK/PD, ADME and DMPK evaluations (strategy development, study design/execution, data analyses to inform lead optimization and candidate selection).
- Represent as functional lead for global regulatory activities and Health Authority engagements (NDA and/or BLA experience is a must).
- Supervise, mentor, and develop a team of high-performing scientists.
- Contribute to platform-based pharmacology activities across novel genetic modalities and disease indications.
- Publish manuscripts and advocate scientific leadership at external conferences.
More About You / Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences or related field + ≥10 years’ biotech/pharma experience.
- Expertise in clinical pharmacology and pharmacometrics principles; strong hands-on modeling and data analytics; proven regulatory success from IND through registration.
- siRNA and/or oligonucleotide experience highly preferred.
- Demonstrated success leading/building high-performing teams.
- Excellent communication, multitasking, and collaboration in cross-functional/matrix environments.
Benefits (explicitly stated)
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application instructions / Other
- Hybrid role: expected to work on-site in the U.S. and/or attend in-person events occasionally.
- Candidates must be authorized to work in the U.S.