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Senior Director, Quantitative & Clinical Pharmacology

Sarepta Therapeutics
5 months ago
Remote friendly (Connecticut, United States)
United States
Clinical Research and Development
The leadership role will develop and execute translational, clinical pharmacology, and pharmacometrics strategies and deliverables from early through late-stage clinical development, managing a team of scientists and serving as a SME.

Responsibilities
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred)
- Serve as therapeutic lead/SME (siRNA or oligonucleotide experience preferred) for clinical pharmacology strategies, protocol preparation, study execution, data review/analysis, and study reports
- Develop and execute translational/mechanistic PK/PD modeling to enable FIH dose selection and early efficacy/safety characterization using biomarkers and disease animal models
- Lead pharmacometrics across all stages (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 and candidate selection)
- 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; publish manuscripts; present at conferences

Qualifications
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field + β‰₯10 years biotech/pharma experience
- Expertise in clinical pharmacology/pharmacometrics, hands-on modeling/data analytics, and regulatory success from IND through registration
- siRNA and/or oligonucleotide experience highly preferred
- Proven team leadership; strong communication/collaboration

Benefits (as stated)
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers

Application instructions
- If you’re a solution-oriented critical thinker, apply.
- Must be authorized to work in the U.S.
- Hybrid; work on-site in the U.S. and attend in-person events as needed.