Senior Director, Quantitative & Clinical Pharmacology
Sarepta Therapeutics
4 months ago
Remote friendly (Texas, 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 support FIH and clinical pharmacology study designs.
- 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 a 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 for clinical pharmacology strategies, protocol prep, study execution, data review/analysis, and study reports.
- Lead translational, mechanistically based PK/PD modeling to support FIH dose identification and early efficacy/safety characterization using biomarkers and disease animal models.
- Lead pharmacometrics strategies across all 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 analysis to inform lead optimization, candidate selection, and nonclinical development).
- Act as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience required).
- Supervise, mentor, and develop scientists.
- Contribute to platform-based pharmacology activities across novel genetic modalities.
- Publish manuscripts; advocate scientific leadership at external conferences.
More About You / Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences (or related) with ≥10 years’ biotech/pharma experience.
- Expertise in clinical pharmacology and pharmacometrics; 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/building high-performing teams with strong people-development focus.
- Excellent communication, multitasking, and collaboration in cross-functional/matrix environments.
Application / Work Location
- Hybrid; expected to work on-site in the U.S. at company facilities and/or attend 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.
- Lead clinical dose selection and refinement across all phases of clinical development.
- Design and support FIH and clinical pharmacology study designs.
- 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 a 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 for clinical pharmacology strategies, protocol prep, study execution, data review/analysis, and study reports.
- Lead translational, mechanistically based PK/PD modeling to support FIH dose identification and early efficacy/safety characterization using biomarkers and disease animal models.
- Lead pharmacometrics strategies across all 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 analysis to inform lead optimization, candidate selection, and nonclinical development).
- Act as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience required).
- Supervise, mentor, and develop scientists.
- Contribute to platform-based pharmacology activities across novel genetic modalities.
- Publish manuscripts; advocate scientific leadership at external conferences.
More About You / Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences (or related) with ≥10 years’ biotech/pharma experience.
- Expertise in clinical pharmacology and pharmacometrics; 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/building high-performing teams with strong people-development focus.
- Excellent communication, multitasking, and collaboration in cross-functional/matrix environments.
Application / Work Location
- Hybrid; expected to work on-site in the U.S. at company facilities and/or attend in-person events from time to time.
- Candidates must be authorized to work in the U.S.