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 Los Angeles, CA, Springhouse, PA, Raritan, NJ, High Wycombe, UK or Beerse, Belgium. Other locations such as Germany, Austria, Switzerland, Netherlands, Poland, Hungary, Spain and France will also be considered.
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, the Clinical Project
Scientist assists in the preparation of protocol writing for and operational
execution of clinical studies. You will participate 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, in this
role you 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. You will assess external clinical research
proposals involving Company products and manuscripts that are being prepared
for publication. You will also serve as a liaison between the Company and
clinical research staff in many countries. Additionally, you 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
• 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
• Understanding how these various functions
work, the Clinical Project Scientist should be capable of implementing
translational medicine approaches for late clinical development.
+ 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
+ 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-New Jersey-Raritan-
Netherlands, Switzerland, Poland, United States, Austria, Belgium, Germany, Spain, France, United Kingdom, Hungary
Janssen Research & Development, LLC (6084)