Johnson & Johnson Careers
Director, Clinical Trial Scientist
Requisition ID: 9810180815
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting an Director, Clinical Trial Scientist to be located in the New Jersey or Pennsylvania area. This position will be located in New Brunswick, NJ, with consideration given to non-local candidates in the United States.
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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Director, Clinical Scientist position will have responsibility working in close collaboration with the Clinical Leader, Non -Clinical leader, Global Clinical Trial Manager and will assist in the preparation of various required documents including but not limited to regulatory documents, protocol writing, ICF, NDA etc. and the operational execution of clinical studies. You will closely interact with translational biomarker group, clinical pharmacology, medical writing, regulatory, statistics and programming, and clinical operations. Operational duties may include ensuring compliance with Good Clinical Practice guidelines and working directly with local trial managers and site monitor for smaller trials, or with the broader Global Clinical Operations group to execute early phase clinical studies. In addition to understanding how these various functions work, you should be capable of implementing translational medicine approaches for late clinical development.
This role is for a unique drug development program that will be performed under a BARDA government contract. The BARDA contract is for the development of the drug as a radiation and chemical countermeasure as well as an Oncology drug for treatment of patients with Hepatocellular Carcinoma and patients with hematologic malignancies undergoing allogeneic bone marrow transplant. This individual will provide functional input into the overall project execution by working in close partnership with other functional leaders.
- Participate in drafting protocol synopses, full protocols, informed consent documents, and will review Case Report Forms (CRFs) and other data collection tools against draft protocols
- You will work together with the Clinical team to mitigate issues in initiation of early phase clinical trials and may participate in review of Monitoring Guidelines, SET charter, the Statistical Analysis Plan, the Data Management Plan, and the Safety Management Plan.
- 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.
- Will also serve as a liaison between the Company and clinical research staff including project CRO, vendors, or staff in other countries.
- Mentor and train site, Company staff and appropriate vendors/ contractors, on the study protocol, ensuring clinical staff have the necessary guidance and tools for performance of various projects.
- You may be asked to participate in drafting documents being submitted to health authorities, and manuscripts or presentations for publication and support and attend advisory boards and scientific round tables.
- The program is a unique program extending from first in human to phase III registrations studies, and experience across all phases of development with an early development emphasis will be highly valued.
- The CPS reports directly to the Clinical 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!
- An Advanced Degree in a scientific discipline (i.e. Masters degree, Ph.D. or Pharm.D. or other equivalent degree) with a minimum of 8 years of experience in a related clinical research position, spending at least part of the time within the pharmaceutical industry is required
- Early development, clinical trial operations and/or medical writing experience is preferred
- Significant knowledge of basic and clinical cancer research and its application to cancer drug development is required
- A successful track record working within a matrix team environment is required
- This position will be located in New Brunswick, NJ, with consideration given to non-local candidates in the United States, and may require up to 25% domestic and international travel
BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
United States-New Jersey-New Brunswick
North America-United States
Johnson & Johnson (6067)
Clinical Research non-MD