Clinical Pharmacology Principal Scientist - MIDD Expert

Johnson & Johnson Innovative Medicine; Spring House (PA); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

Vacation – 120 hours/yr

Sick time – 40-56 hours/yr depending</

Paid holidays – 13 days/yr

Job summary

Johnson & Johnson Innovative Medicine is seeking a Clinical Pharmacology (CP) Principal Scientist to lead CP activities across CPP. You will design PK/PD analyses, contribute to model-informed drug development, and collaborate with cross-functional teams to support development programs.

The role involves writing CP sections for regulatory submissions, leading CP deliverables, and interfacing with regulatory bodies as needed. Travel 5–10% is expected.

Qualifications

• PhD or PharmD with 4+ years of relevant experience.
• Understanding of PK/PD and translational medicine.
• Experience with regulatory guidelines and model-informed drug development.

Responsibilities

• Contribute to compound development strategy using quantitative methods.
• Plan and conduct PK/PD analyses and translate to dose regimens.
• Author CP sections of regulatory documents and CSR.
• Lead CP deliverables in CPP studies within the CDT.

Skills

PK/PD understanding

MIDD knowledge

NONMEM

R

GastroPlus

Simcyp

Matlab

Education

PhD in Pharmaceutical Sciences or Clinical Pharmacology

PharmD or equivalent

Tools

NONMEM

R

GastroPlus

Simcyp

WinNonlin

Matlab

Job description

Johnson & Johnson Innovative Medicine is seeking a Clinical Pharmacology (CP) Principal Scientist to lead CP activities across CPP. You will design PK/PD analyses, contribute to model-informed drug development, and collaborate with cross-functional teams to support development programs.

The role involves writing CP sections for regulatory submissions, leading CP deliverables, and interfacing with regulatory bodies as needed. Travel 5–10% is expected.