Associate Director, Clinical Project Scientist - Late Development Oncology

Johnson & Johnson Spring House , PA 19477

Posted 2 weeks ago

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Clinical Project Scientist supporting solid tumor, clinical development, Oncology. This position is located in any of our Janssen locations such as Spring House, Pa, or Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the company.

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.

We are Janssen. Our mission drives us.

Our patients inspire us. We collaborate with the world for the health of everyone in it.

The current position is in Late Development (LD), reports to a Clinical Scientist and supports the Study Responsible Physician (SRP) and the Study Responsible Scientist (SRS) for one or more clinical trials. As part of the function, in close collaboration with the SRP and SRS(s), the Associate Director, Clinical Project Scientist (CPS) assists in the preparation of protocol writing 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 trial. Furthermore, the CPS will monitor clinical study parameters, deliverables, policy compliance and resource needs, as well as apply scientific discipline to minimize risk and maximize the quality of the study. He or she plays a key role in the medical review of study data and assist in coding, analysis and documentation of Company clinical work.

The CPS will participate in investigator meetings, investigator engagements and the management of sites to ensure study interventions are made per protocol and in alignment with stakeholders within the study team. Collaboration with safety and data management teams and with the Data Monitoring Committee will be required to make timely decision regarding study objectives.

The CPS will assist in the preparation and development of abstracts, posters and manuscripts for publication. The CPS will also serve as a liaison between the Company and global clinical research staff. The CPS will participate in training the central study team, local study team, site personnel or external vendors on protocol, disease evaluation criteria, or other specific aspects of the clinical study..

The position requires a high-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards. 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 Late Development 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. In addition to understanding how these various functions work, the Clinical Project Scientist (CPS) should be capable of implementing translational medicine approaches for late clinical development.

Qualifications

  • Minimum of an advanced degree in a scientific discipline (i.e. Master's, Ph.D. or Pharm.D. or equivalent) or with commensurate clinical research experience is required.

  • A minimum of 5 years of experience in a related clinical research position, spending at least part of the time within the pharmaceutical industry and oncology trials, is preferred.

  • Significant knowledge of basic and clinical cancer research and its application to cancer drug development is important, particularly in oncology.

  • Good oral and written communication skills are essential. Good presentation skills (including report development) are a plus but not 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.

ERADICATE CANCER

Primary Location

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Other Locations

North America-United States-New Jersey-Raritan

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2206038865W



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Associate Director, Clinical Project Scientist - Late Development Oncology

Johnson & Johnson