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:

Cambridge, Massachusetts, United States of America, La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America, West Chester, Pennsylvania, 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 Senior Principal Scientist, Pharmacometrics to be located in Raritan, NJ; Titusville, NJ; Spring House, PA; West Chester, PA; Cambridge, MA; or La Jolla, CA.

Purpose:
The Sr. Principal Scientist, Pharmacometrics position is responsible for the development and execution of pharmacokinetics population pharmacokinetic [PK] and pharmacodynamic [PD] modeling and simulation activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of studies for products in any phase of development. Additional responsibilities include the generation and review of pharmacometric documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies or Advisory Committee Meetings.

The position is responsible for supervising and conducting advanced population PK-PD modeling and simulation exercises. Individual advancement is based, in part, on the degree of experience, displaying a progression in the level of expertise and level of independence shown in contributing to drug development and the advancement of science both internally and externally.

You will be responsible for:

• Conducting advanced pharmacokinetic (PK)/pharmacodynamic (PD) modeling and simulation research with an emphasis on mechanism-based modeling techniques, systems biology and disease progression models.
• Supporting product development by defining dose-concentration-pharmacological effect relationships of a drug using modeling & simulation methodologies from data acquired at various development stages (Phase 1-3).
• Performing population PK/PD analyses in support of regulatory submissions.
• Developing & reviewing study designs, writing analysis plans & reports, analyzing and interpreting PK/PD data and results.
• Identifying opportunities and ways to address drug development questions/issues that qualify to be addressed with linear or nonlinear mixed effects modeling.
• Serving as a technical expert in the application of PK/PD modeling theories, concepts, principles and processes.
• Maintaining liaisons within and outside the organization. Representing the organization on scientific matters within the worldwide scientific community.
• Acting as a trainer and a coach of junior staff within the department.
• Helping to advance the science in the field, identifying and coordinating research collaborations with external parties
• Training new hires and in-house contractors on pharmacometric-related processes
• Participating in and/or expanding knowledge of pharmacometrics and related sciences via internal/external presentations, trainings, educational events, and/or meetings
• Carrying out functional responsibilities in accordance with applicable SOPs/Guidelines and Regulatory requirements
• Assisting in process improvement initiatives and SOP/Guideline development

Qualifications / Requirements:

Education:

• A minimum of a Bachelor's degree is required
• Advanced degree (Master's, PhD) in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacometrics, Chemical/Biomedical Engineering or Biological Sciences is highly preferred

Required:

• Minimum 8-10 years of experience in the pharmaceutical industry/academia setting
• In-depth knowledge of pre-clinical or clinical pharmacokinetics, drug metabolism, and PK/PD modeling, pharmacometric and simulation principles
• Knowledge of statistics and drug development in general
• Established a level of expertise or scientific reputation though multiple publications and presentations
• Advanced knowledge of non-linear mixed effect modeling
• Expertise in using R and NONMEM
• Demonstrated internal and external leadership skills in areas related to pharmacometrics and model-based drug development
• Good written and oral communication skills
• Ability to build and maintain effective working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment
• Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner
• Self-motivated with the ability to work independently with minimal supervision
• Ability to translate creative and innovative approaches into solutions and the timely advancement of projects
• Up to 10% travel – Domestic & International

The anticipated base pay range for this position in the US is $137, 000 to $235, 750.

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 August 8, 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:

$137, 000-$235, 750

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year 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 the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits