Senior Director, Quantitative & Clinical Pharmacology
Sarepta Therapeutics
5 months ago
Remote friendly (Maryland, United States)
United States
Clinical Research and Development
The Opportunity / Importance of the Role
- 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 an SME on programs.
Responsibilities
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease experience preferred).
- Serve as therapeutic lead (siRNA/oligonucleotide experience preferred) and SME in clinical pharmacology strategies, including protocol preparation, study execution, data review/analysis, and study reports.
- Develop and execute translational/mechanistic PK/PD modeling to support FIH dose identification and early efficacy/safety characterization using biomarkers and disease animal models.
- Lead pharmacometrics strategies across all stages of development (population PK, PK/PD modeling/simulations, meta-analysis, disease modeling to inform clinical development).
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy, study design/execution, data analyses to inform lead optimization and candidate selection).
- Represent as functional lead for global regulatory and HA engagements; NDA and/or BLA experience required.
- Supervise, mentor, and develop high-performing scientists.
- Contribute to platform-based pharmacology activities across novel genetic modalities and disease indications.
- Publish manuscripts; advocate scientific leadership at external conferences.
Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field with ≥10 years in biotech or pharmaceutical industry.
- 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 and building high-performing teams.
- Excellent communication, multitasking, and collaboration in cross-functional/matrix environments.
Application / Work Arrangement
- Hybrid role; expected to work on site in the U.S. at Sarepta facilities and/or attend in-person events from time to time.
- 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 an SME on programs.
Responsibilities
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease experience preferred).
- Serve as therapeutic lead (siRNA/oligonucleotide experience preferred) and SME in clinical pharmacology strategies, including protocol preparation, study execution, data review/analysis, and study reports.
- Develop and execute translational/mechanistic PK/PD modeling to support FIH dose identification and early efficacy/safety characterization using biomarkers and disease animal models.
- Lead pharmacometrics strategies across all stages of development (population PK, PK/PD modeling/simulations, meta-analysis, disease modeling to inform clinical development).
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy, study design/execution, data analyses to inform lead optimization and candidate selection).
- Represent as functional lead for global regulatory and HA engagements; NDA and/or BLA experience required.
- Supervise, mentor, and develop high-performing scientists.
- Contribute to platform-based pharmacology activities across novel genetic modalities and disease indications.
- Publish manuscripts; advocate scientific leadership at external conferences.
Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field with ≥10 years in biotech or pharmaceutical industry.
- 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 and building high-performing teams.
- Excellent communication, multitasking, and collaboration in cross-functional/matrix environments.
Application / Work Arrangement
- Hybrid role; expected to work on site in the U.S. at Sarepta facilities and/or attend in-person events from time to time.