At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Pharmacokinetics & Pharmacometrics

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

We are searching for the best talent for a Principal Scientist, Clinical Pharmacology to be in Raritan, NJ; Titusville, NJ; or Spring House, PA.

Purpose:
The Principal Scientist, Clinical Pharmacology will focus on Established Products applying clinical pharmacology knowledge and strategy to manage an array of established products. This includes the design of clinical pharmacology studies or clinical pharmacology components of clinical studies, pharmacokinetics/pharmacodynamics analyses and reporting, and application of principles of model-informed drug development (MIDD), with guidance from senior CPP leaders, to products. With oversight, the Principal Scientist, Clinical Pharmacology may function as the Clinical Pharmacology lead on Compound Development Teams (CDT, ) working in collaboration with cross-functional team members (e.g., Statistics, Pharmacometrics, Clinical, Regulatory etc.) on all clinical pharmacology aspects of the assigned programs.

You will be responsible for:
• Design and implement scientifically robust clinical pharmacology strategies for compounds within the established product portfolio.
• Supply compound development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD (e.g., biomarker, efficacy, and/or safety), subject characteristics, disease states, competitive landscape, and drug interactions to influence go/no go decisions, support subject sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development.
• Translate quantitative knowledge into strategic opportunities to drive development along the model-informed drug development principles and extending this strategy to marketed products.
• Plan appropriate analysis (e.g., non-compartmental PK, population and/or modeling and simulation analysis of PK and/or PD data) of preclinical-clinical translation, dose/exposure-response relationships, to guide dose regimen and optimize study design.
• Summarize and provide interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.
• Carries out functional responsibilities in accordance to applicable SOPs and regulatory requirements
• Design Phase I clinical pharmacology studies and clinical pharmacology components of clinical studies.
• Perform internal data and literature searches and summarize the findings to address health authority inquiries.
• Supply content for IB, INDs, briefing books, submission package, and other regulatory documents as applicable to support clinical studies and/or programs.
• Expand knowledge of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modeling and simulation by engaging with the scientific community (e.g., publishing, presenting etc.) and internalize key takeaways back to Janssen.
• Work effectively in a team environment in accordance with timelines and overall project goals.
• Apply appropriate regulatory (e.g., FDA, EMEA, ICH, etc.) guidelines across activities.
• Apply relevant technical trainings/takeaways to daily responsibilities, with focus of opportunistic deliver of value/impact.

Qualifications / Requirements:

Education:
• Bachelor’s degree is required
• Advanced degree (MS, PharmD, PhD) in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences is highly preferred

Required:
• Minimum of 6-8 years of relevant industry experience
• Minimum of 2 years experience within Clinical Pharmacology
• Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine
• Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab)
• Understanding of overall process of drug development, including model informed drug development (MIDD) and the overall pharmaceutical R& D process
• Working knowledge of US, European, and Asian (including BRIC countries) regulatory requirements and guidelines
• Good oral and written communication skills, including ability to interpret PK and PKPD results and prepare presentations to communicate findings effectively
• Has established a level of expertise and scientific reputation through publications and/or presentations

The anticipated base pay range for this position in the US is $115, 000 to $197, 800.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https: //www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on May 22, 2025. The Company may however extend this time-period, in which case the posting will remain available on https: //www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

The anticipated base pay range for this position is:

$115, 000 - $197, 800

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http: //www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.