Clinical Pharmacology Principal Scientist

Johnson & Johnson

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

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, pharmacokinetics, and pharmacodynamics, with a strong ability to design and analyze clinical studies while adhering to regulatory guidelines. Proficient in model-informed drug development and advanced analysis methodologies to support drug development strategies.

Highest-signal resume keywords

Clinical Pharmacology ExpertisePharmacokinetics/Pharmacodynamics AnalysisModel-Informed Drug DevelopmentRegulatory Guidelines KnowledgeAdvanced Analysis Methods

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Applicant Tracking System Keywords

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Hard Skills

PharmacokineticsPharmacodynamicsPopulation AnalysisModeling and SimulationClinical Study DesignData InterpretationQuantitative MethodsDrug Development ProcessRegulatory Document AuthoringQuality Control

Soft Skills

Oral CommunicationWritten Communication

Tools & Technologies

NONMEMRGastroplusSimcypWinnonlinMatlab

Certifications & Qualifications

PhD in Pharmaceutical SciencesPharmD Degree

Industry Keywords

FDA GuidelinesEMEA GuidelinesICH GuidelinesTranslational MedicinePharmaceutical R&D

About the role

Key responsibilities & impact

Apply clinical pharmacology knowledge to design clinical pharmacology studies and clinical study components
Perform pharmacokinetics/pharmacodynamics analyses and reporting
Apply model-informed drug development principles to studies and programs
Contribute to compound development strategy using quantitative methods and nonclinical, PK, PD, patient, disease, competitive, and drug-interaction data
Plan and perform non-compartmental, population, modeling, and simulation analyses
Summarize and interpret PK and PK/PD analysis results and their impact on development programs and clinical use
Contribute to the design and execution of clinical studies and pharmacology strategies
Plan and conduct PK and PK/PD analyses, perform independent QC, and report results through presentations, memos, and CSRs
Design Phase I clinical pharmacology studies and clinical pharmacology 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 as needed
Contribute to clinical pharmacology, model-informed drug development, analysis methodology, and drug development knowledge through publications, presentations, and professional societies
Manage CP deliverables in a matrix environment according to timelines and project goals
Apply FDA, EMEA, ICH, and other regulatory guidelines to clinical development plans and studies

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 the overall drug development process, including model-informed drug development (MIDD) and pharmaceutical R&D
Working knowledge of regulatory requirements and guidelines
Good oral and written communication skills, including interpreting PK and PKPD results and preparing 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; 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