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 Senior Clinical
Project Scientist (CPS) in the Oncology Therapeutic Area. The position will preferably
be based out of Springhouse (PA, USA) or Raritan (NJ, USA); or alternatively
out of Beerse (Belgium), Leiden (The Netherlands) or High Wycombe (UK).
The current position is in Late
Development (LD) and requires supporting the Daratumumab development program,
specifically for phase 3 cancer studies in Multiple Myeloma, supporting the
Study Responsible Physician (SRP).
The Senior Clinical Project Scientist (CPS) will be
responsible for the following, but not limited to:
- As part of
the role, collaborating with the SRP and the Molecule Responsible
Physician (MRP), the CPS assists in the preparation
of protocol writing for and operational execution of clinical studies.
- The CPS 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
- Furthermore, the CPS 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 CPS 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
- Work with
safety, data management teams and Data Monitoring Committee to make timely
decision regarding study objectives.
- The CPS will assess external clinical
research proposals involving Company products and manuscripts that are
being prepared for publication.
- The CPS will also serve as a liaison
between the Company and clinical research staff in many countries.
- The CPS 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.
- The role requires a high-performing and
energetic individual who demonstrates outstanding scientific knowledge
applicable to oncology clinical research and the highest personal and
- The successful candidate 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.
- The position will also require
capabilities to work on additional LD studies moving into operation in
- This will involve close
interaction and working closely with the discovery, biomarkers, clinical
pharmacology, companion diagnostic development team, regulatory,
statistics and operations. In addition to understanding how these various
functions work, the CPS should be capable of implementing translational
medicine approaches for late clinical development.
- The CPS reports directly to the Clinical Research Leader for the product to which he/she is
- This position requires a minimum of an advanced degree in a
scientific discipline (i.e. M.S, Ph.D. or Pharm.D. or equivalent).
- A minimum of 5 years of experience in a related clinical
research position, spending at least part of the time within the
pharmaceutical industry, is preferred. Significant knowledge of basic and
clinical cancer research and its application to cancer drug development is
- Good oral and written communication skills are essential.
Good presentation skills (including report development) are a plus but not
- Successful work experience in a matrix team environment with
cross functional teams is required.
- A strong commitment to oncology clinical research and the
ability to work well within a team setting are essential.
- Travel may be required and may be up to 15 % annually
(international, as well as domestic).
United States-Pennsylvania-Spring HouseOther Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Research non-MDRequisition ID