Senior Director, Quantitative & Clinical Pharmacology
Sarepta Therapeutics
5 months ago
Remote friendly (New York, 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.
- Lead clinical dose selection and refinement across all phases of clinical development.
- Design and execute FIH and clinical pharmacology studies.
- Develop and apply MIDD using population and statistically based methodologies.
- Apply mechanistic and translational PK/PD approaches.
- Manage a team of scientists and serve as an SME on programs.
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 (siRNA or oligonucleotide experience preferred) and SME in clinical pharmacology strategies, protocol preparation, study execution, data review/analysis, and study reports.
- Lead translational/mechanistic 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 of development (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 analysis) 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 scientists.
- Contribute to platform-based pharmacology activities across novel genetic modalities and disease indications.
- Publish manuscripts; advocate scientific leadership at external conferences.
More About You
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field with ≥10 years biotech/pharma industry experience.
- Expert knowledge of clinical pharmacology and pharmacometrics; 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 a commitment to people development.
- Excellent communication, multitasking, and collaboration in cross-functional/matrix environments.
Benefits
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application Instructions
- Candidates are encouraged to apply.
- Develop and execute translational, clinical pharmacology, and pharmacometrics strategies and deliverables from early through late-stage clinical development.
- Lead clinical dose selection and refinement across all phases of clinical development.
- Design and execute FIH and clinical pharmacology studies.
- Develop and apply MIDD using population and statistically based methodologies.
- Apply mechanistic and translational PK/PD approaches.
- Manage a team of scientists and serve as an SME on programs.
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 (siRNA or oligonucleotide experience preferred) and SME in clinical pharmacology strategies, protocol preparation, study execution, data review/analysis, and study reports.
- Lead translational/mechanistic 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 of development (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 analysis) 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 scientists.
- Contribute to platform-based pharmacology activities across novel genetic modalities and disease indications.
- Publish manuscripts; advocate scientific leadership at external conferences.
More About You
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field with ≥10 years biotech/pharma industry experience.
- Expert knowledge of clinical pharmacology and pharmacometrics; 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 a commitment to people development.
- Excellent communication, multitasking, and collaboration in cross-functional/matrix environments.
Benefits
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application Instructions
- Candidates are encouraged to apply.