Senior Principal Scientist, Pharmacometrics

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 proc