Clinical Pharmacology (CP) Principal Scientist (Pharmacokinetics)

Location: Spring House, Pennsylvania, United States of America, or Titusville, New Jersey, United States of America; hybrid work arrangement

Salary: $117,000–$201,250 per year

Company

Johnson & Johnson MedTech develops healthcare solutions and innovative medicines aimed at preventing, treating, and curing complex diseases.

What you will do

• Contribute quantitative clinical pharmacology and pharmacometrics expertise to compound development strategies and go/no-go decisions.
• Design Phase I clinical pharmacology studies and clinical pharmacology components of broader clinical studies.
• Perform PK, PD, PK/PD, population, preclinical-to-clinical translation, and modeling and simulation analyses.
• Interpret analysis results to support dose selection, exposure-response evaluation, patient sub-population decisions, and study optimization.
• Manage operational elements of CPP studies and deliver CP materials for presentations, memoranda, clinical study reports, and regulatory submissions.
• Collaborate with compound development teams, Pharmacometrics, regulatory stakeholders, and cross-functional partners in a matrix environment.

Requirements

• PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacometrics, Biomedical Engineering, or a relevant Biological Science, plus 4+ years of relevant experience; or PharmD or equivalent with 4+ years of relevant experience.
• Understanding of PK, PD, PK/PD, translational medicine, and the pharmaceutical research and development process.
• Knowledge of advanced analysis methods such as population analysis, PBPK, and QSP.
• Experience or understanding of modeling tools including NONMEM, R, GastroPlus, Simcyp, WinNonlin, and MATLAB.
• Working knowledge of regulatory requirements and guidelines, including FDA, EMEA, and ICH guidance.
• Strong oral and written communication skills and willingness to travel 5–10%.

Culture & Benefits

• Work in a science-driven, patient-focused healthcare organization.
• Collaborate in a matrix environment with teams across clinical development and pharmacometrics.
• Retirement pension and 401(k) savings plans are available.
• Participation in a long-term incentive program.
• Paid vacation, sick time, holidays, parental, caregiver, bereavement, volunteer, and military spouse leave.