Senior Director, Quantitative & Clinical Pharmacology
Sarepta Therapeutics
5 months ago
Remote friendly (Virginia, 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.
- Manage a team of scientists and serve as a SME on programs.
Responsibilities / Opportunity to Make a Difference
- 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; support clinical study protocol preparation, study execution, data review/analysis, and study reports.
- Lead development and execution of translational and mechanistically based PK/PD modeling to support FIH dose identification and early efficacy/safety characterization using biomarkers and disease animal models.
- Lead and execute pharmacometrics strategies across all development 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, data analyses for lead optimization and candidate selection).
- Represent as functional lead for global regulatory activities and health authority (HA) 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.
Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field with ≥ 10 years of biotech/pharmaceutical industry experience.
- Expertise in clinical pharmacology and pharmacometrics principles; hands-on modeling and data analytics; proven regulatory interaction success from IND through registration.
- siRNA and/or oligonucleotide experience highly preferred.
- Demonstrated success leading and building high-performing teams; strong commitment to people development.
- Excellent communication, multitasking, and collaboration skills in cross-functional/matrix environments.
Benefits
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application / Work Location Notes
- This position is hybrid; expected to work on site at a U.S. facility and/or attend company-sponsored in-person events from time to time.
- 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.
- Manage a team of scientists and serve as a SME on programs.
Responsibilities / Opportunity to Make a Difference
- 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; support clinical study protocol preparation, study execution, data review/analysis, and study reports.
- Lead development and execution of translational and mechanistically based PK/PD modeling to support FIH dose identification and early efficacy/safety characterization using biomarkers and disease animal models.
- Lead and execute pharmacometrics strategies across all development 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, data analyses for lead optimization and candidate selection).
- Represent as functional lead for global regulatory activities and health authority (HA) 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.
Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field with ≥ 10 years of biotech/pharmaceutical industry experience.
- Expertise in clinical pharmacology and pharmacometrics principles; hands-on modeling and data analytics; proven regulatory interaction success from IND through registration.
- siRNA and/or oligonucleotide experience highly preferred.
- Demonstrated success leading and building high-performing teams; strong commitment to people development.
- Excellent communication, multitasking, and collaboration skills in cross-functional/matrix environments.
Benefits
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application / Work Location Notes
- This position is hybrid; expected to work on site at a U.S. facility and/or attend company-sponsored in-person events from time to time.
- Candidates must be authorized to work in the U.S.