Senior Director, Quantitative & Clinical Pharmacology
Sarepta Therapeutics
5 months ago
Remote friendly (Georgia, United States)
United States
Clinical Research and Development
The Importance of the Role
Developing and executing translational, clinical pharmacology and pharmacometrics strategies and deliverables from early through late-stage clinical development. Manage a team of scientists and serve as a SME on programs.
Responsibilities
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred)
- Serve as therapeutic lead and SME in clinical pharmacology strategies; support protocol preparation, study execution, data review/analysis, and study reports
- Lead translational and mechanistically based PK/PD modeling to enable FIH dose identification and early efficacy/safety characterization using biomarkers and disease animal models
- Lead pharmacometrics strategies across all stages of drug development (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 and candidate selection)
- 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 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 and the scientific community
Qualifications
- 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; hands-on experience in modeling and data analytics
- Proven success in regulatory interactions from IND through registration
- siRNA and/or oligonucleotide experience highly preferred
- Demonstrated success leading and building high-performing teams
Required/Preferred Skills
- Strong communication, multitasking, and collaboration skills in cross-functional/matrix environments
Benefits
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers
Application Instructions
- Apply if you are a solution-oriented, critical thinker comfortable with ambiguity and candor, and you value kindness and integrity.
Developing and executing translational, clinical pharmacology and pharmacometrics strategies and deliverables from early through late-stage clinical development. Manage a team of scientists and serve as a SME on programs.
Responsibilities
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred)
- Serve as therapeutic lead and SME in clinical pharmacology strategies; support protocol preparation, study execution, data review/analysis, and study reports
- Lead translational and mechanistically based PK/PD modeling to enable FIH dose identification and early efficacy/safety characterization using biomarkers and disease animal models
- Lead pharmacometrics strategies across all stages of drug development (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 and candidate selection)
- 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 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 and the scientific community
Qualifications
- 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; hands-on experience in modeling and data analytics
- Proven success in regulatory interactions from IND through registration
- siRNA and/or oligonucleotide experience highly preferred
- Demonstrated success leading and building high-performing teams
Required/Preferred Skills
- Strong communication, multitasking, and collaboration skills in cross-functional/matrix environments
Benefits
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers
Application Instructions
- Apply if you are a solution-oriented, critical thinker comfortable with ambiguity and candor, and you value kindness and integrity.