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Director Clinical Research-00000CTC
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 a Director Clinical Research, Oncology, located in Los Angeles, CA.
The oncology portfolio includes abiraterone acetate (Zytiga), which was recently approved in the US and Europe 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, combination studies with docetaxel and other agents, and a randomized Phase 2 trial in breast cancer. Registration-directed Zytiga clinical trials form the treatment of prostate cancer are ongoing in Japan, China, and other countries in Asia-Pacific. Other late stage programs at JNJ include Velcade, ibrutinib, Yondelis, and Siltuximab.
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The Director Clinical Research, 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 Director supports the Medical Leader/Clinical Leader 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, clinical pharmacology, and health economics.
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 Director Clinical Research, Oncology assists in the preparation of protocol writing for and operational execution of clinical studies. He/She participates in the interpretation and reporting of the results of the research, including submission to health authorities. He/She evaluates scientific information and new ideas to assist in identifying new research opportunities. The Director supports medical affairs activities involving product evaluation, labeling and surveillance. He/She will assess external clinical research proposals involving company products and manuscripts that are being prepared for publication. The Director acts as a liaison between the company and clinical investigators. The Director develops, in concert with senior clinical staff, credible relationships with opinion leaders, and clinical research staff in many countries.
The Director Clinical Research, Oncology reports directly to a Medical Leader/Clinical Leader for the product to which he/she is assigned.
This position requires a minimum of an advanced degree in medicine (i.e. M.D or DO or equivalent). A trained Oncologist (Board certified or eligible) is strongly preferred. Applicable post-doctoral fellowship training is required. A minimum of 3 years experience in a clinical research position 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, written communication and presentation skills (including report development) are essential. Successful work experience in a matrix team environment with cross functional teams is required. The ability to use influencing skills is a must. A strong commitment to oncology clinical research and the ability to work well within a team setting are essential. Travel required may be up to 20 % 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 MD
Deadline: Wednesday, 31 July 2013