Clinical Pharmacology Lead — Driving Drug Development

Johnson & Johnson Innovative Medicine; Titusville (NJ); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

Vacation time

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Caregiver Leave

Volunteer Leave

401(k) Plan

Long-term incentives

Job summary

Johnson & Johnson Innovative Medicine seeks a Clinical Pharmacology (CP) Principal Scientist to apply pharmacology principles to clinical studies, PK/PD analyses, and model-informed drug development across programs from pre-NME to post-marketing. You will lead CP analyses and contribute to regulatory submissions in a matrix CPP team.

Responsibilities include designing Phase I CP studies, managing CP deliverables, and communicating complex PK/PD findings to cross-functional partners.

Qualifications

• PhD or PharmD with 4+ years of relevant experience.
• Understanding of PK, PD, PK/PD and Translational Medicine.
• Experience with MIDD and regulatory guidelines.
• Excellent oral and written communication skills.

Responsibilities

• Plan and perform PK/PD analyses for translation across preclinical to clinical data.
• Design Phase I CP studies and CP components of studies.
• Prepare CP sections of IBs, briefing books and regulatory submissions.
• Manage CPP study operations and ensure timely CP deliverables.
• Represent CPP in regulatory interactions when needed.

Skills

PK/PD

Translational Med

Regulatory knowledge

Communication

Travel 5–10%

Education

PhD in Pharmaceutical Sciences

PharmD degree

Tools

NONMEM

R

GastroPlus

Simcyp

WinNonlin

MATLAB

Job description

Johnson & Johnson Innovative Medicine seeks a Clinical Pharmacology (CP) Principal Scientist to apply pharmacology principles to clinical studies, PK/PD analyses, and model-informed drug development across programs from pre-NME to post-marketing. You will lead CP analyses and contribute to regulatory submissions in a matrix CPP team.

Responsibilities include designing Phase I CP studies, managing CP deliverables, and communicating complex PK/PD findings to cross-functional partners.