Senior Director, Quantitative & Clinical Pharmacology
Sarepta Therapeutics
5 months ago
Remote friendly (Massachusetts, United States)
United States
Clinical Research and Development
The 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 (siRNA or oligonucleotide experience preferred) for clinical pharmacology strategies; clinical protocol preparation; study execution; data review/analysis; and study reports.
- Develop and execute translational, mechanistically based PK/PD modeling to identify FIH dose and characterize efficacy and safety using biomarkers and disease animal models.
- Lead pharmacometrics strategies across all stages of drug development, including population PK, PK/PD modeling and simulations, meta-analysis, and 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, candidate selection, and nonclinical drug development.
- Act as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience required).
- 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
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field with ≥10 years’ experience 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 with strong people development.
- Excellent communication, multitasking, and collaboration in cross-functional/matrixed environments.
Benefits (explicitly stated)
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application/Work Details
- Hybrid role; expected to work on-site in the U.S. and/or attend company-sponsored in-person events from time to time.
- Candidates must be authorized to work in the U.S.
- 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; clinical protocol preparation; study execution; data review/analysis; and study reports.
- Develop and execute translational, mechanistically based PK/PD modeling to identify FIH dose and characterize efficacy and safety using biomarkers and disease animal models.
- Lead pharmacometrics strategies across all stages of drug development, including population PK, PK/PD modeling and simulations, meta-analysis, and 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, candidate selection, and nonclinical drug development.
- Act as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience required).
- 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
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field with ≥10 years’ experience 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 with strong people development.
- Excellent communication, multitasking, and collaboration in cross-functional/matrixed environments.
Benefits (explicitly stated)
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application/Work Details
- Hybrid role; expected to work on-site in the U.S. and/or attend company-sponsored in-person events from time to time.
- Candidates must be authorized to work in the U.S.