Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director Clinical Project Scientist (Immunology) to be located in Spring House, PA.
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.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
• The Clinical Project Scientist is a responsible member of the pediatric development team dedicated to the development and execution of clinical trials and the clinical and operational implementation of a complex compound program.
• The Clinical Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity. Specifically, the Clinical Scientist provides input to the pediatric development plan, develops the pediatric trial protocol and trial materials, takes responsibility for coordinating completion of study reports, and supports preparation of relevant documents for regulatory filings.
• Responsible for design, execution, safety monitoring, and reporting of Phase 1,2 and 3 pediatric clinical trials in collaboration with study responsible physician.
• Leads the development of the Pediatric Investigational Plans and Pediatric Study Plans
• Provides significant strategic input to pediatric drug development group
• Collaborates with early and late development clinical teams and Compound Development Teams to align pediatric strategy
• This role involves extensive team matrix interactions with a number of different disciplines. The position will also have responsibility for various activities associated with safety monitoring and assessment of relevant clinical studies/programs, and will have clinical ownership of or provide clinical support for various regulatory documents, including the Investigator Brochure, the Risk Template of the Informed Consent form, the Development Safety Update Report (DSUR), the Periodic Benefit Risk Evaluation Report (PBRER) and the Safety Risk Management Plan.
• Supports the Global Clinical Development Operations group with trial set up, conduct, and monitoring, and database locks.
• Integral in the collection and analysis of clinical trial data, and assists with completion of clinical study reports
• Support the assessment and review of clinical safety data from studies by collecting and summarizing appropriate safety data/information for review by the Molecule Responsible Physician (MRP) and/or Study Responsible Physicians (SRPs) or Safety Management Team (SMT).
• Assists in the evaluation of adverse events and supports the interpretation and reporting of results. This will include attending and presenting at SMT
• Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting
• Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
• Responsible for data review in conjunction with other clinical team members prior to database locks
• Participate in Immunology TA initiatives as requested
• Participate on and may lead cross-functional teams for evaluation of new product ideas
• Reviews medical literature and related new technologies
• A minimum of a Bachelor's degree is required
• Advanced degree (MD, MS, RN, RD, PhD or PharmD) is preferred.
• Pediatric specific experience is preferred but not required.
• A minimum of at least 5 years of clinical research and development experience within the Pharmaceutical, Medical Device OR CRO industry or experience as clinical research coordinator in non-industry setting is required.
• Clinical research operational knowledge, strong project planning/management and excellent communication skills is required
• Ability to operate with limited day to day supervision is required
• Independent decision-making and analytical skills are required.
• Successful work experience in a matrix team environment with cross functional teams is required.
• Travel up to 10 % of time both domestic and international may be required
Johnson & Johnson is an equal opportunity employer
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)
Clinical Research non-MD