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.
Early Development Clinical Scientist
EMPLOYEE JOB PROFILE (EJP) – JOB DESCRIPTION
Clinical Scientist, Early Development
Research and Early Development
Functional Area Description
The Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
Position Summary / Objective
1. Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct.
2. May lead or support trial level activities for one or more trials with the necessary supervision.
1. Collaborate and liaise with external partners (e.g., KOLs).
2. Seek out and enact best practices with instruction.
3. Provide regular and timely updates to manager/management as requested.
4. Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.
5. Conduct literature review.
6. Develop site and CRA training materials and present these at SIVs and Investigator meetings.
7. Review clinical narratives.
8. Collaborate cross-functionally to monitor clinical data for specific trends.
9. Contribute to the development of Data Review Plan in collaboration with Data Management.
10. Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
11. 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.)
12. Submit clinical documents to TMF.
Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
1. Expectation of 2+ years of experience in clinical science, clinical research, or equivalent.
2. Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
3. Ability to understand assigned protocol(s) and their requirements.
4. Knowledge and skills to support program-specific data review and trend identification.
5. Intermediate medical writing skills and medical terminology.
6. Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
Key Competency Requirements
1. Basic planning/project management skills (develop short range plans that are realistic and effective)
2. Basic knowledge of disease area, compound, current clinical landscape.
3. Detail-oriented with commitment to quality
4. Intermediate critical thinking and problem-solving skills.
5. Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
6. Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., patient profiles, report generating tools)
1. Domestic and international travel may be required (approximately 10-20%)
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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