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Principal Scientist, Clinical Pharmacology, Pharmacometrics
Johnson & Johnson. Devise clinical pharmacology and model-informed drug development strategies using quantitative methods .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical pharmacology and model-informed drug development, with a strong foundation in pharmacokinetics (PK), pharmacodynamics (PD), and advanced analysis methods. Proficient in regulatory strategy and capable of delivering impactful clinical pharmacology strategies for drug development.
Highest-signal resume keywords
PhD In Pharmaceutical Sciences5+ Years Experience In Pharmaceutical FieldsUnderstanding Of PK, PD, PK/PDModel-Informed Drug Development (MIDD)Proficiency In NONMEM, R, Gastroplus
ATS Keywords
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Hard Skills
Clinical Pharmacology StrategiesPopulation AnalysisModeling And Simulation AnalysesPK/PD AnalysisDose/Exposure-Response RelationshipsPhase I Clinical Pharmacology StudiesRegulatory Document PreparationData IntegrationProduct Differentiation StrategiesScientific Knowledge Contribution
Soft Skills
Good Oral Communication SkillsGood Written Communication SkillsPresentation Skills
Tools & Technologies
NONMEMRGastroplusSimcypWinnonlinMatlab
Industry Keywords
Pharmaceutical R&D ProcessTranslational MedicineRegulatory RequirementsBusiness Development OpportunitiesClinical Pharmacology
About the role
Key responsibilities & impact- Devise clinical pharmacology and model-informed drug development strategies using quantitative methods
- Integrate nonclinical data, PK, PD, patient characteristics, disease states, competitive landscape, and drug interactions to support development decisions
- Support sub-population, dose, dosage regimen, and study-design selection
- Plan, perform, or oversee non-compartmental, population, modeling, and simulation analyses
- Analyze preclinical-clinical translation and dose/exposure-response relationships
- Plan, summarize, and interpret PK and PK/PD analysis results
- Deliver clinical pharmacology strategies for development candidates
- Design Phase I clinical pharmacology studies and apply alternate modeling approaches
- Manage and/or supervise elements of CPP studies
- Develop product differentiation strategies
- Define regulatory strategy and prepare CP contributions to regulatory documents
- Represent Clinical Pharmacology in external regulatory meetings
- Evaluate potential business development opportunities
- Contribute to scientific knowledge through publishing, presentations, professional societies, and technical advancement
- Manage CP deliverables in accordance with timelines and project goals
Requirements
What you’ll need- PhD, or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences
- 5+ years of experience in pharmaceutical or related fields
- Understanding of PK, PD, PK/PD, and/or Translational Medicine
- Understanding of advanced analysis methods, including population analysis, PBPK, and QSP
- Understanding of modeling tools including NONMEM, R, Gastroplus, Simcyp, Winnonlin, and Matlab
- Understanding of model-informed drug development (MIDD) and the overall pharmaceutical R&D process
- Working knowledge of regulatory requirements and guidelines
- Good oral and written communication skills
- Ability to interpret PK and PKPD results and prepare presentations
- Willingness to undertake approximately 5% domestic and international travel
Benefits
Comp & perks- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Inclusive interview process and disability accommodations