Senior Clinical Research Scientist, Oncology

Organisation Description

Description

PURPOSE OF ROLETo provide scientific expertise to develop and support Phase I-IV clinical trials/projects in accordance with Clinical Development plans agreed by the Oncology Project Team.
FUNCTIONAL KNOWLEDGE:Provides scientific input for clinical development plansWrites scientific rationale for clinical trial protocols, including most recent literature citationsReview, analyze and summarize appropriate scientific literature related to clinical development plans, pre-investigational new drug applications (pre-IND), IND, new drug application (NDA) or biologic license application (BLA), and draft adhoc sections of these documents, and interpret and communicate key aspects to internal and external audiences. .Assist in the development, drafting, and supervision of clinical submissions to FDA and ex-US regulatory authorities in pre-IND, IND, EOPI, EOPII, and BLA phases of the development programs. Provide input and expertise as needed to internal groups including Discovery, Pre-clinical, Marketing, etc. Review external research proposals, and provide guidance to the Medical Director. Liaises with discovery, external experts, external partners to accumulate scientific and medical knowledge necessary to support clinical development planDrives creation and annual update of IB liasing with Toxicology, Pharmacology, Safety, Regulatory and Medical Communication ExpertsCommunicates and trains clinical development representatives in new scientific directions within the therapeutic areaWorks with CDU and Medical Communications Group to ensure the publication plans for the Therapeutic Area are in line with the strategic messages.Assists RMDs in creation of proposed concept sheets for Phase IIIb/IV with a therapeutic areaWorks closely with Medical Communications to ensure all relevant documentation is updated with new medical information, including assuming responsibility for the incorporation of new information into the Investigator BrochureActs as scientific expert on the products in the therapy areaWorks with the Medical Directors, liaises with Corporate Communications as product experts within the Therapeutic AreaAttends scientific meetings to remain abreast of new developments within the Therapeutic Area.Give seminars on specific products in the pipeline with input from medical colleaguesWrite peer-reviewed papers to summarize results of scientific experiments that may be part of a clinical trialMaintain a database of cited literature, and supervise archiving of scientific documentsInvites experts to give seminars in the Therapeutic area field (mechanism of disease, animal models of disease, genomics and pharmacogenomics, current therapies). BUSINESS EXPERTISEUp-to-date knowledge of new developments in Therapeutic Area (mechanisms of disease and new drugs && competitors).Up-to-date knowledge of the drug development processUp-to-date knowledge of the company, Serono products and the Serono pipeline (especially in the TA) EDUCATION/LANGUAGESPhD or MD/PhD degree in cancer biology, pharmacology, immunology, molecular genetics or other health-allied sciences with strong cancer cell biology core. Minimum o7 years of pharmaceutical clinical drug development experience including, excellent understanding of protocol development, study initiation and follow-up, IRB/EC submissions and interactions; and if appropriate, review of clinical study data listings ; review and/or preparation of adhoc sections of clinical study reports. Experience and/or training in cancer immunology, cancer biology, monoclonal antibodies, biologics, or closely related disciplines is highly desirable; a strong interest in clinical immunology and ability to grasp fundamental immunologic concepts (particularly in the field of T cell biology) and their relevance to clinical application is required. Solid scientific skills are required, and a publication track record in basic oncology or cancer cell biology areas is highly desirable. Experience interacting with academic institutions, government cancer research agencies, CROs, and central laboratory venders is a plus. PROFESSIONAL SKILLS && EXPERIENCEExperience in product && clinical development (at least 7 years in an industrial or comparable setting) in position of increasing responsibility.Familiarity with translational medicine and concepts in molecular oncology, including, pharmacogenomics, cancer genomics, proteomics, immunohistochemistry, and biomedical imaging, etc.Ability to perform in-depth literature searches and to utilize library servicesComputer literacy PERSONAL SKILLS && COMPETENCIESExcellent written and oral communication skills, including fluency in English, are critical. Specifically, the candidate must be able to communicate effectively with investigators, research sites, and internal stakeholders; to summarize and communicate scientific data; to synthesize and communicate relevant findings from the literature; and to prepare and give oral presentations to internal and external groups. The candidate must be able to build and maintain excellent interpersonal relationships, both within and outside the company, at all levels.Ability to work in a matrix organizationThe candidate should be self-motivated, highly proactive and should demonstrate ability to work in a team environment