Senior Clinical Project Scientist – Late Development Oncology, Bladder – Johnson & Johnson – Spring House, PA

Janssen Pharmaceutical, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Senior Clinical Project Scientist, Solid Tumors-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 Senior Clinical Scientist, Late Development (LD) Oncology works in the Oncology Therapeutic Area Late Development group. He/she reports to a LD Clinical Scientist and supports the Study Responsible Physician (SRP) and the Study Responsible Scientist (SRS) for one or more clinical studies. The Senior Clinical Scientist 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. He/She will monitor clinical study parameters, deliverables, and policy compliance as well as apply scientific discipline to minimize risk and maximize the quality of the study. He/She plays a key role in the medical review of study data and assists in coding, analysis and documentation of Company clinical work. This will involve close interaction and working closely with the discovery, biomarkers, clinical pharmacology, companion diagnostic development team, regulatory, statistics and operations.

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 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 Senior Clinical Scientist position involves but may not be limited to the following essential job functions:

• Participate in drafting protocol synopses, full protocols and/or amendments, and informed consent documents.
• Participate in review of Monitoring Guidelines, SET/DRC/IDMC charter(s), the Statistical Analysis Plan, the Data Management Plan, and the Safety Management Plan.
• Liaise with Translational Research (pharmacokinetic operations & biomarker operations) to ensure sample collection, processing and tracking.
• Liaise with Integrated Data Analysis & Reporting in set-up of data visualization tools (eg, iDARTs).
• Conduct review of clinical data in conjunction with the Study Responsible Scientist(s) and Study Responsible Physician in real time including patient screening results, adverse events and other data pertinent to study endpoints.
• Work within the cross-functional Late Development Clinical Trial Team to plan, execute and oversee patient-oriented late phase clinical trials.
• Collaborate closely with the Study Responsible Scientist(s) in the execution of oncology LD clinical trials.
• May 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.
• May participate in drafting documents for Health Care Authority interactions

Qualifications

• An advanced degree such as a Master’s degree, Ph.D. or Pharm. D or with commensurate clinical research experience is required.
• A minimum of 2 years of experience in a related clinical research position, spending at least part of the time within the pharmaceutical industry, is preferred.
• Knowledge of basic and translational research with an understanding of applications to cancer drug development is required.
• The ability to work in a matrix team environment and adherence to the highest personal and ethical standards with a commitment to patient-centered clinical research are essential 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.

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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
2206040618W