Janssen Research and Development, L.L.C., a member of Johnson & Johnson's Family of Companies, with a specific focus on the field of Oncology, has a position for a Director, Clinical Project Scientist in the Oncology Therapeutic Area. The position will be based out of Springhouse, PA or Raritan, NJ Up to 15% domestic and international travel is required.
The current position is in Late Development (LD) and requires supporting a Late-Development Compound program, specifically running phase 2-3 cancer studies, supporting the Study Responsible Physician (SRP). As part of the role, collaborating with the SRP and the Molecule Responsible Physician (MRP), the CSc assists in the preparation of protocol writing for and operational execution of clinical studies. The CSc participates in the start-up of global clinical studies, ensuring on schedule site activation and subject enrollment, monitoring, compliance with department safety practices, policies, procedures as well as the day to day management of a clinical trial. Furthermore, the CSc will implement clinical study parameters, deliverables, policy compliance and resource needs, apply scientific discipline to minimize risk and increase performance, play a key role in the medical review of study data and timely and high-quality data entry and assist in coding, analysis and documentation of Company clinical work.
The Director, Clinical Project Scientist will participate in investigator meetings, investigator engagement, managing sites to ensure study treatment discontinuation decisions are made per protocol and align with stakeholders within the study team. Work with safety, data management teams and Data Monitoring Committee to make timely decision regarding study objectives. The CSc will assess external clinical research proposals involving Company products and manuscripts that are being prepared for publication. The CSc will also serve as a liaison between the Company and clinical research staff in many countries. The CSc will participate in the training of site and Company staff on the study protocol, ensure the clinical staff have the necessary guidance and tools for performance of various projects.
? High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards.
? Must be equally comfortable among the team to which he/she is assigned and in the global environment in which the Company operates. The program is in an accelerated development mode and experience with registrations studies will be highly valued.
? Require capabilities to work on additional LD studies moving into operation in later years. This will involve close interaction and working closely with the discovery, biomarkers, clinical pharmacology, companion diagnostic development team, regulatory, statistics and operations.
? Understanding how these various functions work, the CSc should be capable of implementing translational medicine approaches for late clinical development.
? Reports directly to a Medical Leader/Clinical Leader for the product to which he/she is assigned.
? Advanced Degree in a Scientific discipline (i.e. M.S, Ph.D. or Pharm.D. or equivalent work experience) is required.
? A minimum of 8 years of experience in a related clinical research position is required. Spending at least part of the time within the pharmaceutical industry, is preferred.
? Significant knowledge of clinical cancer research and its application to cancer drug development is required. Good oral and written communication skills are essential. Must have strong data analytics skills.
? Good presentation skills (including report development) is a requirement.
? Successful work experience in a matrix team environment with cross functional teams is required
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-
North America-United States-New Jersey-Raritan, North America-United States-California-La Jolla
Janssen Research & Development, LLC. (6084)
Clinical Research non-MD
768####### Associated topics: ancmg, aoa, breast, cancer, hem onc, hematology, oncology, palliative, physician md, physician md do
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.