Senior Quantitative Clinical Pharmacology Lead
3 weeks ago
We are seeking an exceptional Senior Quantitative Clinical Pharmacology Lead to join our team at Sarepta Therapeutics. As a critical member of our development team, you will be responsible for providing translational, clinical pharmacology and pharmacometrics deliverables for development assets from pre-IND to Phase III.
In this role, you will apply advanced quantitative modeling methodologies to integrate, analyze, and interpret diverse data sources, including pharmacokinetics, pharmacodynamics, and disease progression modeling. You will drive and support pharmacology and pharmacometrics activities involved in dose selection and characterizing interactions between drugs, patients, and biological systems.
Key Responsibilities:- Perform advanced quantitative pharmacology, pharmacometrics, and disease progression analyses and activities within assigned programs to yield high-value population PK, PK/PD, and disease progression modeling support for critical decision-making.
- Manage and develop translational and clinical pharmacology efforts, including study designs, protocol preparation, data analytics, and reporting.
- Co-develop the quantitative clinical pharmacology strategy and execute or implement strategy with minimal oversight.
- Support and contribute to regulatory communications and IND/NDA/BLA sections related to clinical pharmacology and pharmacometrics.
- Ph.D. degree in pharmaceutical sciences, pharmacometrics, biomedical engineering, statistics, applied mathematics, or a related field with a minimum of 3 years of experience working as a clinical pharmacology or pharmacometrician within the pharmaceutical industry.
- Experience in developing population PK, PK/PD, exposure-response, disease progression modeling, and other model-based analyses to aid in research and development decision-making.
- Proficiency in R, NONMEM, Phoenix, Monolix, or other similar programming languages.
- Experience in ASO, GTx, or rare diseases is a plus.
- Knowledge of Health Authority perspectives on the use of modeling and simulation.
- Excellent interpersonal, collaboration, English communication skills (both written and verbal).
- Strong analytical skills and strategic thinking.
Sarepta Therapeutics offers a competitive compensation and benefit package. We value diversity, equity, and inclusion and are committed to creating a workplace where everyone feels valued and respected.
The estimated salary for this position is $132,000 - $165,000 per year, based on industry standards and location considerations.
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