Clinical Scientist - Cell Therapy (R1543605-en-us-5)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
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.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.