Senior Director, Quantitative & Clinical Pharmacology
Sarepta Therapeutics
5 months ago
Remote friendly (New Jersey, United States)
United States
Clinical Research and Development
The Importance of the Role
This leadership role will be developing and executing translational, clinical pharmacology and pharmacometrics strategies and deliverables from early through late-stage clinical development, including:
- Clinical dose selection and refinement across all phases of clinical development
- FIH and clinical pharmacology study designs
- Development and hands-on application of MIDD using population and statistically based methodologies
- Mechanistic and translational PK/PD approaches
- Managing a team of scientists and serving as a SME on programs
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, protocol preparation, study execution, data review/analysis, and study reports
- Lead translational and mechanistically based PK/PD modeling to enable identification of FIH dose and early efficacy/safety characterization using biomarkers and disease animal models
- Lead and execute pharmacometrics strategies across all stages, including population PK, PK/PD modeling and simulations, meta-analysis, and disease modeling
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy development, study design/execution, data analyses)
- Represent as functional lead for global regulatory activities and HA engagements; NDA and/or BLA experience is required
- Supervise, mentor, and develop a team of scientists
- Contribute to platform-based pharmacology across novel genetic modalities and disease indications
- Publish manuscripts and advocate scientific leadership at external conferences
More About You (Qualifications)
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences or related field with ≥10 years of biotech/pharmaceutical industry experience
- Expertise in clinical pharmacology and pharmacometrics principles; strong hands-on modeling and data analytics; proven success in regulatory interactions from IND through registration
- siRNA and/or Oligonucleotide experience highly preferred
- Demonstrated success leading/building high-performing teams; strong commitment to people development
- Excellent communication, multitasking, and collaboration in cross-functional/matrixed environments
Application Instructions
- Apply if you are a solution-oriented, critical thinker comfortable with ambiguity and candor.
Benefits
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers
This leadership role will be developing and executing translational, clinical pharmacology and pharmacometrics strategies and deliverables from early through late-stage clinical development, including:
- Clinical dose selection and refinement across all phases of clinical development
- FIH and clinical pharmacology study designs
- Development and hands-on application of MIDD using population and statistically based methodologies
- Mechanistic and translational PK/PD approaches
- Managing a team of scientists and serving as a SME on programs
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, protocol preparation, study execution, data review/analysis, and study reports
- Lead translational and mechanistically based PK/PD modeling to enable identification of FIH dose and early efficacy/safety characterization using biomarkers and disease animal models
- Lead and execute pharmacometrics strategies across all stages, including population PK, PK/PD modeling and simulations, meta-analysis, and disease modeling
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy development, study design/execution, data analyses)
- Represent as functional lead for global regulatory activities and HA engagements; NDA and/or BLA experience is required
- Supervise, mentor, and develop a team of scientists
- Contribute to platform-based pharmacology across novel genetic modalities and disease indications
- Publish manuscripts and advocate scientific leadership at external conferences
More About You (Qualifications)
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences or related field with ≥10 years of biotech/pharmaceutical industry experience
- Expertise in clinical pharmacology and pharmacometrics principles; strong hands-on modeling and data analytics; proven success in regulatory interactions from IND through registration
- siRNA and/or Oligonucleotide experience highly preferred
- Demonstrated success leading/building high-performing teams; strong commitment to people development
- Excellent communication, multitasking, and collaboration in cross-functional/matrixed environments
Application Instructions
- Apply if you are a solution-oriented, critical thinker comfortable with ambiguity and candor.
Benefits
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers