Senior Director, Quantitative & Clinical Pharmacology
Sarepta Therapeutics
5 months ago
Remote friendly (North Carolina, United States)
United States
Clinical Research and Development
The Importance of the Role
- Develop and execute translational, clinical pharmacology, and pharmacometrics strategies and deliverables across early through late-stage clinical development.
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred).
- Act as therapeutic lead and SME (siRNA/oligonucleotide experience preferred) for clinical pharmacology strategies, protocol preparation, study execution, data review/analysis, and study reports.
- Lead translational/mechanistic PK/PD modeling to enable FIH dose identification; early efficacy/safety characterization using biomarkers and disease animal models.
- Lead pharmacometrics strategies across development (population PK, PK/PD modeling/simulations, meta-analysis, disease modeling).
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy, study design/execution, analyses for lead optimization/candidate selection).
- Lead global regulatory activities and HA engagements (NDA and/or BLA experience required).
- Supervise, mentor, and develop scientists; contribute to platform pharmacology across genetic modalities.
- Publish manuscripts and advocate at external conferences/scientific community.
More About You
- PhD in Clinical Pharmacology/Pharmacometrics/Pharmaceutical Sciences or related field; ≥10 years in biotech/pharma.
- Strong hands-on modeling/data analytics; clinical pharmacology & pharmacometrics expertise; regulatory success from IND through registration.
- siRNA and/or oligonucleotide experience highly preferred.
- Proven team leadership; strong communication, multitasking, and collaboration in cross-functional/matrix teams.
Benefits (if applicable)
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Application Instructions
- Apply if you’re solution-oriented, comfortable with ambiguity, and bring candor, kindness, and integrity to your work and peers.
- Develop and execute translational, clinical pharmacology, and pharmacometrics strategies and deliverables across early through late-stage clinical development.
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred).
- Act as therapeutic lead and SME (siRNA/oligonucleotide experience preferred) for clinical pharmacology strategies, protocol preparation, study execution, data review/analysis, and study reports.
- Lead translational/mechanistic PK/PD modeling to enable FIH dose identification; early efficacy/safety characterization using biomarkers and disease animal models.
- Lead pharmacometrics strategies across development (population PK, PK/PD modeling/simulations, meta-analysis, disease modeling).
- Support non-clinical PK/PD, ADME, and DMPK evaluations (strategy, study design/execution, analyses for lead optimization/candidate selection).
- Lead global regulatory activities and HA engagements (NDA and/or BLA experience required).
- Supervise, mentor, and develop scientists; contribute to platform pharmacology across genetic modalities.
- Publish manuscripts and advocate at external conferences/scientific community.
More About You
- PhD in Clinical Pharmacology/Pharmacometrics/Pharmaceutical Sciences or related field; ≥10 years in biotech/pharma.
- Strong hands-on modeling/data analytics; clinical pharmacology & pharmacometrics expertise; regulatory success from IND through registration.
- siRNA and/or oligonucleotide experience highly preferred.
- Proven team leadership; strong communication, multitasking, and collaboration in cross-functional/matrix teams.
Benefits (if applicable)
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Application Instructions
- Apply if you’re solution-oriented, comfortable with ambiguity, and bring candor, kindness, and integrity to your work and peers.