Associate Director, Quantitative Clinical Pharmacology
Sarepta Therapeutics
14 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
The Associate Director, Quantitative Clinical Pharmacology provides translational, clinical pharmacology, and pharmacometrics deliverables for development assets from pre-IND to Phase III. Applies quantitative modeling methods (population PK, PK/PD, and disease progression modeling using multivariate statistical and empirical approaches) to integrate, analyze, and interpret diverse data sources (pharmacokinetics; pharmacodynamics including biomarker & imaging; electronic health records). Drives pharmacology and pharmacometrics activities for dose selection and characterizing interactions between drugs, patients, and biological systems to identify key predictors.
Responsibilities
- Develop and execute quantitative pharmacology strategies across development stages through product registration
- Lead clinical pharmacology expertise across clinical/translational development (protocol preparation, study execution, data review/analysis, study reports)
- Conduct advanced pharmacometrics analyses (population PK, PK/PD modeling and simulation, meta-analysis, disease modeling) to support clinical decisions and dose selection
- Serve as functional lead for global regulatory strategies and regulatory documents
- Maintain and share leading-edge knowledge (publish manuscripts; present at scientific conferences/forums)
Qualifications
- PhD in Pharmaceutical Sciences, mathematics/engineering, or related field + at least 5 years’ experience in clinical pharmacology or pharmacometrics
- Strong knowledge of clinical pharmacology principles; hands-on PK/PD modeling analysis; experience with regulatory interactions
- Experience developing advanced pharmacometrics/PK/PD/PBPK models; skilled with software such as NONMEM, R, and Phoenix
- Excellent communication, multitasking, collaboration
- Strong analytical and strategic thinking
Benefits (explicitly mentioned)
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers
Application
- Encouraged to apply (position is hybrid; work on site in the U.S. and/or attend in-person events periodically)
- Candidates must be authorized to work in the U.S.
Responsibilities
- Develop and execute quantitative pharmacology strategies across development stages through product registration
- Lead clinical pharmacology expertise across clinical/translational development (protocol preparation, study execution, data review/analysis, study reports)
- Conduct advanced pharmacometrics analyses (population PK, PK/PD modeling and simulation, meta-analysis, disease modeling) to support clinical decisions and dose selection
- Serve as functional lead for global regulatory strategies and regulatory documents
- Maintain and share leading-edge knowledge (publish manuscripts; present at scientific conferences/forums)
Qualifications
- PhD in Pharmaceutical Sciences, mathematics/engineering, or related field + at least 5 years’ experience in clinical pharmacology or pharmacometrics
- Strong knowledge of clinical pharmacology principles; hands-on PK/PD modeling analysis; experience with regulatory interactions
- Experience developing advanced pharmacometrics/PK/PD/PBPK models; skilled with software such as NONMEM, R, and Phoenix
- Excellent communication, multitasking, collaboration
- Strong analytical and strategic thinking
Benefits (explicitly mentioned)
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers
Application
- Encouraged to apply (position is hybrid; work on site in the U.S. and/or attend in-person events periodically)
- Candidates must be authorized to work in the U.S.