Clinical Scientist, Early Clinical Development-Oncology/Hematology

hace 2 días


Madrid, España Be-It Ltd A tiempo completo

.Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.The Early Clinical Development (ECD-HOCT) team at BMS is responsible for hematology, oncology and cell therapy pipeline assets and sits at the interface between discovery and translational science and clinical drug development. Composed of physician-scientists and clinical-scientists, this group oversees the early development of both internal and partnered assets covering all platforms of therapies, including small molecules, traditional and complex biologics and next gen cell therapies. Therapeutic areas span the full range of hematologic and solid tumor indications.Position Summary/Objective: Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct.May lead or support trial level activities for one or more trials with the necessary supervision.Position Responsibilities: Collaborate and liaise with external partners (e.G., KOLs).Seek out and enact best practices with instruction.Provide regular and timely updates to manager/management as requested.Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.Conduct literature review.Develop site and CRA training materials and present these at SIVs and Investigator meetings.Review clinical narratives.Collaborate cross-functionally to monitor clinical data for specific trends.Contribute to the development of Data Review Plan in collaboration with Data Management.Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.G., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)Submit clinical documents to TMF.Degree Requirements: Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred)



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