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Director, Quantitative Clinical Pharmacology – PK/PD Modeling & Strategy
SAREPTA. Lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development through Ph3 and product registration .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical pharmacology and pharmacometrics, with a strong focus on PK/PD modeling, regulatory strategy, and data analysis. Proven ability to lead drug development projects and engage with health authorities while maintaining cutting-edge knowledge in the field.
Highest-signal resume keywords
PhD In Pharmaceutical SciencesClinical Pharmacology ExpertisePK/PD Modeling AnalysisRegulatory Interactions ExperienceNONMEM & R Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Pharmacology PrinciplesQuantitative Pharmacology StrategiesModel-Based Data AnalysesPopulation PK ModelingPK/PD ModelingMeta-AnalysisDisease Modeling
Soft Skills
Excellent CommunicationMultitasking SkillsCollaboration Skills
Tools & Technologies
NONMEMR
Industry Keywords
Clinical DevelopmentTranslational DevelopmentHealth Authority EngagementsSiRNA ExperienceCNS Experience
About the role
Key responsibilities & impact- Lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development through Ph3 and product registration
- Drive development and execution of quantitative pharmacology strategies across all stages of drug development
- Lead clinical pharmacology expertise in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, and study reports
- Conduct model-based data analyses including population PK, PK/PD modeling and simulation, meta-analysis, and disease modeling
- Serve as functional lead for global regulatory strategies and health authority engagements
- Maintain leading-edge knowledge, publish manuscripts, and present at scientific conferences and forums
Requirements
What you’ll need- PhD in Pharmaceutical Sciences, mathematics/engineering or related field
- 7 years of experience working in clinical pharmacology or pharmacometrics
- Strong understanding of clinical pharmacology principles
- Strong hands-on experience with PK/PD modeling analysis
- Experience in regulatory interactions
- Excellent communication, multitasking, and collaboration skills
- Experience in NONMEM & R highly preferred
- siRNA and/or CNS experience preferred
- Candidates must be authorized to work in the U.S.
Benefits
Comp & perks- Physical and Emotional Wellness resources
- Financial Wellness resources
- Support for Caregivers
- Comprehensive benefits
- Competitive compensation and benefit package