Senior Director, Quantitative & Clinical Pharmacology
Sarepta Therapeutics
5 months ago
Remote friendly (Washington, DC)
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.
- Emphasize clinical dose selection and refinement across all phases of clinical development.
- Lead FIH and clinical pharmacology study designs.
- Develop and apply MIDD using population and statistically based methodologies.
- Apply mechanistic and translational PK/PD approaches.
Key Responsibilities
- 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, protocol preparation, study execution, data review/analysis, and study reports (siRNA or oligonucleotide experience preferred).
- 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/simulations, meta-analysis, disease modeling).
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy, study design/execution, analyses for lead optimization and candidate selection).
- Act as functional lead for global regulatory activities and HA engagements; NDA and/or BLA experience is a must.
- 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’ biotech/pharmaceutical industry experience.
- Expertise in clinical pharmacology and pharmacometrics principles; strong 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/matrixed environments.
Benefits (explicitly stated)
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application Instructions / Work Authorization
- Apply if you are solution-oriented and comfortable with ambiguity and candor.
- This is a hybrid role (on-site in the U.S. and/or occasional company-sponsored in-person events).
- 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.
- Emphasize clinical dose selection and refinement across all phases of clinical development.
- Lead FIH and clinical pharmacology study designs.
- Develop and apply MIDD using population and statistically based methodologies.
- Apply mechanistic and translational PK/PD approaches.
Key Responsibilities
- 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, protocol preparation, study execution, data review/analysis, and study reports (siRNA or oligonucleotide experience preferred).
- 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/simulations, meta-analysis, disease modeling).
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy, study design/execution, analyses for lead optimization and candidate selection).
- Act as functional lead for global regulatory activities and HA engagements; NDA and/or BLA experience is a must.
- 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’ biotech/pharmaceutical industry experience.
- Expertise in clinical pharmacology and pharmacometrics principles; strong 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/matrixed environments.
Benefits (explicitly stated)
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application Instructions / Work Authorization
- Apply if you are solution-oriented and comfortable with ambiguity and candor.
- This is a hybrid role (on-site in the U.S. and/or occasional company-sponsored in-person events).
- Candidates must be authorized to work in the U.S.