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Associate Director, Clinical Project Scientist-7911140103
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, is recruiting for an Associate Director, Clinical Project Scientist in the Oncology Therapeutic Area, located in Los Angeles, CA or La Jolla, CA.
The oncology portfolio includes abiraterone acetate (ZYTIGA), which is approved for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC). Other ongoing Zytiga company sponsored trials include: Phase 3 clinical trial in hormone-naïve metastatic prostate cancer and combination studies with docetaxel and other agents. Registration-directed Zytiga clinical trials form the treatment of prostate cancer are ongoing in Japan, China, and other countries in Asia-Pacific. ARN-509 was recently acquired from Aragon Pharmaceuticals, a next-generation androgen receptor antagonist being developed for non-metastatic CRPC as well as other prostate cancer disease indications. Other late stage programs at JNJ include Velcade, ibrutinib, daratumumab, Yondelis, and Siltuximab.
Janssen thrives on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer
The Associate Director, Clinical Project Scientist, Oncology is a member of a matrix team dedicated to the implementation of clinical research studies that are part of a global compound development program. The Associate Director supports the Medical Leader/Clinical Leader of a global Phase 3 study and provides active scientific contributions to a cross-functional clinical team developing a compound currently being studied for new oncology applications. Other functional groups represented on the team include project management, regulatory affairs, global clinical operations, data management, medical writing, biostatistics, medical affairs, and clinical pharmacology.
The role 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 Associate Director, Clinical Project Scientist, in the Oncology Therapeutic Area assists in the preparation of protocol writing for and operational execution of clinical studies. He/She 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 assess external clinical research proposals involving company products and manuscripts that are being prepared for publication. The Associate Director will also serve as a liaison between the company and clinical research staff in many countries. The Associate Director 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 Associate Director, Clinical Project Scientist, Oncology reports directly to a Medical Leader/Clinical Leader for the product to which he/she is assigned.
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This position requires a minimum of an advanced degree in a scientific discipline (i.e. Ph.D. or Pharm.D. or equivalent). 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 preferred. Significant knowledge of basic and clinical cancer research and its application to cancer drug development is important. Good oral andwritten 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. 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).
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Primary Location: North America-United States-California-Los Angeles
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Research non-MD
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