At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We discover and develop innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Bring your talents to our mission, visit http://www.janssenrnd.com/ to learn more.
The Clinical Project Scientist position is in Late Development and supports the Oncology clinical development program, specifically for phase 3 cancer studies in Multiple Myeloma.
In collaboration with the Study Responsible Physician (SRP) and the Molecule Responsible Physician (MRP), you will assist in the preparation of protocol writing and the operational execution of clinical studies. You will closely interact with biomarkers, clinical pharmacology, medical writing, regulatory, statistics and programming, and clinical operations. In addition to understanding how these various functions work, you should be capable of implementing translational medicine approaches for late clinical development.
You will participate in the start-up activities of global clinical studies, ensuring on-schedule site activation and subject enrollment, monitoring, and compliance with department safety SOPs as well as the day to day management of a clinical trial.
You will implement clinical study parameters, deliverables, policy compliance and resource needs, applying scientific discipline to minimize risk and increase performance.
Play a key role in the medical review of study data and assist in coding, analysis and documentation of Company clinical work.
You may participate in investigator meetings, ensuring investigator engagement and managing sites to ensure study treatment discontinuation decisions are made per protocol and aligned with partners within the study team.
Work with safety, data management teams and Data Monitoring Committee to make timely decisions regarding study objectives.
Assess external clinical research proposals involving Company products and manuscripts that are being prepared for publication.
Will also serve as a liaison between the Company and clinical research staff in many countries.
Mentor and train site and Company staff on the study protocol, ensuring clinical staff have the necessary guidance and tools for performance of various projects.
The program is in an accelerated development mode and experience with registrations studies will be highly valued.
The CPS reports directly to the Clinical Project Scientist Leader.
Are you a result focused, high-energy individual who demonstrates excellent scientific knowledge and the highest personal and ethical standards?
Do you possess a strong dedication to oncology clinical research? If yes, then you may be who we are looking for!
A minimum of an advanced degree in a scientific discipline (i.e. M.S, Ph.D. or Pharm.D. or equivalent) with 5 or more years of experience in a related clinical research position, spending at least part of the time within the pharmaceutical industry is required.
Significant knowledge of basic and clinical cancer research and its application to cancer drug development is required.
You are equally comfortable interacting with both the local team and with your global counterparts.
Strong communication skills are expected and you have a successful track record within a matrix team environment.
Travel up to 15 % annually (international, as well as domestic).
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Pennsylvania-Spring House
Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
Clinical Research non-MD
Johnson & Johnson