Clinical Pharmacology Principal Scientist

Johnson & Johnson

. Apply clinical pharmacology knowledge to design clinical pharmacology studies and clinical pharmacology components of clinical studies .

Posted 10/8/2026full-timeUnited StatesLead💰 $117,000 - $201,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical pharmacology study design, pharmacokinetics and pharmacodynamics analysis, and regulatory compliance. Proficient in applying model-informed drug development principles and advanced analysis methods to support drug development strategies.

Highest-signal resume keywords

Clinical Pharmacology Study DesignPharmacokinetics/Pharmacodynamics AnalysisModel-Informed Drug DevelopmentRegulatory Guidelines ComplianceAdvanced Analysis Methods

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacokineticsPharmacodynamicsPopulation AnalysisModeling and SimulationNon-Compartmental AnalysisTranslational MedicineClinical Study DesignDrug Development StrategyQuality ControlData Interpretation

Soft Skills

Oral CommunicationWritten Communication

Tools & Technologies

NONMEMRGastroplusSimcypWinnonlinMatlab

Certifications & Qualifications

PhD in Pharmaceutical SciencesPharmD Degree

Industry Keywords

FDA GuidelinesEMEA GuidelinesICH GuidelinesClinical PharmacologyPharmaceutical R&D

About the role

Key responsibilities & impact

Apply clinical pharmacology knowledge to design clinical pharmacology studies and clinical pharmacology components of clinical studies
Perform pharmacokinetics/pharmacodynamics analyses and reporting
Apply model-informed drug development principles to assigned studies and programs
Contribute to compound development strategy using quantitative methods and integrated nonclinical, PK, PD, patient, disease, competitive, and drug-interaction data
Plan and perform non-compartmental, population, modeling, and simulation analyses
Interpret PK and PK/PD analysis results and assess their impact on development programs and clinical use
Contribute to the design and execution of clinical studies and pharmacology strategies
Conduct PK and PK/PD analyses, independent quality control, and reporting through presentations, memos, and clinical study reports
Design Phase I clinical pharmacology studies and study components consistent with regulatory guidelines
Manage operational elements of CPP studies
Author clinical pharmacology sections of investigator brochures, briefing books, submission packages, and other regulatory documents
Represent CPP at regulatory interactions when needed
Contribute to clinical pharmacology and drug development knowledge through publications, presentations, and professional society participation
Manage clinical pharmacology deliverables in a matrix environment according to timelines and project goals
Apply FDA, EMEA, ICH, and other applicable regulatory guidelines

Requirements

What you’ll need

PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacometrics, Biomedical Engineering, or relevant Biological Sciences, with 4+ years of relevant experience
PharmD degree or equivalent, with 4+ years of relevant experience
Understanding of PK, PD, PK/PD, and/or Translational Medicine
Understanding of advanced analysis methods, such as population analysis, PBPK, and QSP
Understanding of modeling tools such as 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, including ability to interpret PK and PKPD results and prepare presentations
Able to travel 5-10%

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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 the 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Hybrid work arrangement