Clinical Scientist - Cell Therapy (R1558770-it-it-1)
In Bristol Myers Squibb, siamo ispirati da un'unica visione: trasformare la vita dei pazienti attraverso la scienza. In oncologia, ematologia, immunologia e malattie cardiovascolari - una delle pipeline più diversificate e promettenti del settore - ciascuno dei nostri colleghi contribuisce con passione alle innovazioni che guidano un cambiamento significativo. Diamo un tocco umano a ogni trattamento di cui siamo pionieri. Unisciti a noi e fai la differenza.
Functional Area Description
The Clinical Scientist function in Cell Therapy provides scientific expertise necessary to design and deliver clinical studies and programs.
Position Summary / Objective
- Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
- May serve as Clinical Trial Lead for one or more trials
- May lead or support trial level activities for one or more trials with the necessary supervision
- May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members
- 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
- Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
- Conduct literature review
- Submit clinical documents to TMF
- Develop site and CRA training materials and present these at SIVs and Investigator meetings
- Review clinical narratives
- Monitor clinical data for specific trends
- Develop 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
- Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry)
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Ability to understand assigned protocol(s) and their requirements
- Basic knowledge skills to support program-specific data review and trend identification
- Intermediate medical writing skills and medical terminology
- Basic planning/project management skills (develop short range plans that are realistic and effective)
Key Competency Requirements
- Detail-oriented with commitment to quality
- Basic knowledge of disease area, compound, current clinical landscape
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
- Intermediate critical thinking and problem-solving skills
- Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
- Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)
Domestic and International travel may be required.
In tutto il mondo, lavoriamo con passione per avere un impatto sulla vita dei pazienti con malattie gravi. Incoraggiati ad utilizzare i nostri talenti individuali e le diverse prospettive in una cultura inclusiva, i nostri valori condivisi di passione, innovazione, urgenza, responsabilità, inclusione e integrità fanno emergere il massimo potenziale di ciascuno dei nostri colleghi.
Bristol Myers Squibb riconosce l'importanza dell'equilibrio e della flessibilità nel nostro ambiente di lavoro. Offriamo un'ampia varietà di vantaggi competitivi, servizi e programmi che forniscono ai nostri dipendenti le risorse per perseguire i loro obiettivi, sia sul lavoro che nella vita personale.