Senior Director, Quantitative & Clinical Pharmacology
Listed on 2026-07-08
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Research/Development
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Healthcare
Role Overview
This leadership role will be developing and executing translational, clinical pharmacology and pharmacometrics strategies and deliverables from early through late-stage clinical development. Key areas of emphasis will include 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, as well as mechanistic and translational PK/PD approaches.
The role will manage a team of scientists and serve as SME on programs.
- Lead clinical pharmacology and pharmacometrics work streams in CNS diseases (rare disease drug development experience preferred)
- Represent as therapeutic lead (siRNA or oligonucleotide experience preferred) and SME in clinical pharmacology strategies, clinical study protocol preparation, study execution, data review/analysis, and study reports
- Lead the development and execution of translational and mechanistically based PK/PD modeling to enable identification of FIH dose, early characterization of efficacy and safety using biomarkers and disease animal models
- Lead and execute pharmacometrics strategies across all stages of drug development including population PK, PK/PD modeling and simulations, meta‑analysis, disease modeling to inform clinical development
- Support non‑clinical PK/PD, ADME and DMPK evaluations including strategy development, study design and execution, data analyses to inform lead optimization, candidate selection and non‑clinical drug development
- Represent as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience is a must)
- Supervise, mentor and develop a team of high‑performing scientists
- Contribute to platform‑based pharmacology activities across novel genetic modalities and disease indications
- Encompass leading‑edge knowledge in clinical pharmacology and pharmacometrics discipline, publish manuscripts
- Advocate scientific leadership at external conferences and scientific community
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences or related field with ≥ 10 years of experience in biotech or pharmaceutical industry
- Expertise in clinical pharmacology and pharmacometrics principles, strong hands‑on experience in modeling and data analytics, and proven success in regulatory interactions from IND through registration
- siRNA and/or Oligonucleotide experience highly preferred
- Demonstrated success in leading and building high‑performing teams, with a strong commitment to people development
- Excellent communication, multitasking, and collaboration skills in cross‑functional and matrixed team environments
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
For a full list of our comprehensive benefits, see our website:
Location and CompensationThis position is hybrid; you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company‑sponsored in‑person events from time to time.
The targeted salary range for this position is $222,400 - $278,000 per year. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Equal Opportunity StatementSarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e‑Verify.
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