Janssen Research & Development, L.L.C., a Johnson & Johnson company, is looking for a Senior Scientist, Pharmacometrics to be located in Spring House PA, Chesterbrook PA, La Jolla CA, San Francisco CA, Brisbane CA, Titusville NJ or Raritan NJ. Remote work options in the United States may be considered on a case-by-case basis and if approved by the Company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Objective of Position

The Senior Scientist, Pharmacometrics is responsible for the co-development and execution PK/PD Modeling and Simulation activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of ClinPharm-sponsored and -supported studies for products in any phase of development. Additional responsibilities include the generation and review of clinical pharmacology documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies and Advisory Committee Meetings.

The position is responsible for contributing to (all) or conducting advanced research (e.g., model-based population PK and PK/PD drug development). Individual advancement is based, in part, on the educational background, degree of experience, displaying a progression in the level of expertise and level of independence shown.

Senior Scientist, Pharmacometrics Main Accountabilities

• The key tasks can be formulated into 3 main pillars:
• Perform population PK/ PKPD analyses and report writing in support of regulatory submissions
• Support of “Big Impact” product development projects in all stages of drug development using mechanism-based modeling & simulation methodologies (systems biology, disease progression
• modelling, landscape analysis, etc..) using data acquired at various development stages or using literate searched data.
• Perform exploratory modelling projects asking quick turnaround to support critical business decisions
• Beyond and as a result of the above, support and input is given into: Development and review of ClinPharm Population PK study design sections in clinical trial protocols and assistance is provided to the ClinPharm Leader in the defence of the synopsis and protocols at Synopsis Review Committee (SRC) and Protocol Review Committee (PRC) meetings
• Assists the ClinPharm Leader in the overall ClinPharm development strategy, the design of specific ClinPharm studies including the design of modeling and simulation-based assessments within clinical Phase 2/3 studies
• Collaboration, when applicable, with the ClinPharm Leader and ClinPharm Program Manager in the evaluation of Contract Research Organization (CRO) capabilities. Actively participates in the review and monitoring of outsourced Population PK/PD-related activities
• Working in close collaboration with the Biostatistics and Programming group
• Writes population PK/ PKPD analysis plans
• Development/writing/reviewing (including QC) ClinPharm sections of various internal documents and presentations.
• Establish scientific credibility inside and outside the company (e.g., abstracts, posters, publication in peer reviewed journal, podium presentation at conferences)
• Initiate and contribute to the development of new scientific methodologies, while ensuring high quality standards
• Demonstrates in-depth knowledge/expertise in Clinical Pharmacology and/or associated disciplines by developing scientific projects and effectively applies state-of-the-art scientific knowledge to these projects

Qualifications

Minimum Qualifications / Experience

• Ph.D. Degree or equivalent (eg PharmD), with 2-7 years of relevant experience (including postdoctoral studies)
• Ability to apply knowledge of clinical PK & PK/PD concepts and use common modeling tools
• Experience in 1 or more therapeutic areas
• Has begun to establish a level of expertise or scientific reputation though publications and presentations at external meetings
• Good written and oral communication skills (communication)
• Ability to build and maintain effective working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships)
• 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 (planning, organizing and time management)
• Actively identifying new areas for learning, and application to the job (continuous learning)
• Good sense of cultural sensitivity and diversity (cultural diversity)
• Self-motivated with the ability to work independently with minimal supervision (personal accountability)
• Ability to interface with people of various groups (e.g., clinical, bioanalytical, data management, etc) and disciplines

Other Minimal Requirements

• Estimated travel of about 5% of time (Scientist and above)

The anticipated base pay range for this position is $106,500 to $178,400. 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.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.