Senior Director, Quantitative & Clinical Pharmacology
Sarepta Therapeutics
5 months ago
Remote friendly (Ohio, United States)
United States
Clinical Research and Development
The Opportunity
- Develop and execute translational, clinical pharmacology, and pharmacometrics strategies and deliverables across early to 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 (siRNA or oligonucleotide experience preferred) for clinical pharmacology strategies, protocol preparation, study execution, data review/analysis, and study reports.
- Develop and execute translational, mechanistic PK/PD modeling to enable identification of FIH dose and early characterization of efficacy and safety using biomarkers and disease animal models.
- Lead pharmacometrics strategies across drug development stages (population PK, PK/PD modeling and simulations, meta-analysis, disease modeling).
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy development, study design/execution, data analyses to inform lead optimization, candidate selection, and nonclinical development).
- Act as functional lead for global regulatory activities and Health Authority engagements (NDA and/or BLA experience required).
- Supervise, mentor, and develop a team of 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 in biotech/pharmaceutical industry.
- Expert knowledge in clinical pharmacology and pharmacometrics with 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 with commitment to people development.
- Excellent communication, multitasking, and collaboration in cross-functional/matrixed environments.
Benefits
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application Instructions
- Apply if you are solution-oriented, comfortable with ambiguity and candor, and prioritize kindness and integrity.
- Develop and execute translational, clinical pharmacology, and pharmacometrics strategies and deliverables across early to 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 (siRNA or oligonucleotide experience preferred) for clinical pharmacology strategies, protocol preparation, study execution, data review/analysis, and study reports.
- Develop and execute translational, mechanistic PK/PD modeling to enable identification of FIH dose and early characterization of efficacy and safety using biomarkers and disease animal models.
- Lead pharmacometrics strategies across drug development stages (population PK, PK/PD modeling and simulations, meta-analysis, disease modeling).
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy development, study design/execution, data analyses to inform lead optimization, candidate selection, and nonclinical development).
- Act as functional lead for global regulatory activities and Health Authority engagements (NDA and/or BLA experience required).
- Supervise, mentor, and develop a team of 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 in biotech/pharmaceutical industry.
- Expert knowledge in clinical pharmacology and pharmacometrics with 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 with commitment to people development.
- Excellent communication, multitasking, and collaboration in cross-functional/matrixed environments.
Benefits
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application Instructions
- Apply if you are solution-oriented, comfortable with ambiguity and candor, and prioritize kindness and integrity.