Clinical Scientist Team Lead
vor 11 Stunden
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.
**Functional Area Description**
The Clinical Scientist Team Lead reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs.
**Position Summary / Objective**
- Leads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team
- Manages and supervises a team of senior and junior Clinical Scientists to execute trial level activities for multiple trials
- Ensures consistency across studies and provide oversight of all clinical studies within assigned area
- May serve as a Clinical Trial Lead or Co-Lead as needed
- May represent the Clinical Scientist function in various process improvement initiatives and/or cross functional activities
- Serves as a key cross functional collaborator; initial point of escalation cross functions
**Position Responsibilities**
- Collaborate with Program Lead Scientist and Clinical Development Lead to support development of clinical development and lifecycle planning
- Lead implementation of assigned clinical development and/or lifecycle plans
- Maintain an advanced understanding of all protocols within assigned Program
- Provide scientific and clinical leadership to support all activities to advance the assigned plans; Provide program/study/therapeutic area/skills training to team members
- Represent Clinical Scientist Team on the Development Team as appropriate/requested
- Support resourcing and budget planning activities for team
- Review and present data and information to external investigators and internal stakeholders as needed
- Identify and liaise with internal and external collaborators independently and oversee collaboration between clinical scientist and external partners for scientific advice
- Lead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr. Management
- Author/Review abstracts/publications
- Oversee, contribute to, and ensure quality execution of deliverables for all phases of assigned trials (start up/conduct/closure), through activities such as:
- Evaluation of innovative trial designs
- Protocol and ICF development
- Site-facing activities
- CRA training materials
- Data quality activities; ensure consistent, quality data review across trial teams
- Investigator Meetings, SIVs, Advisory Board, and Study committee (e.g., DMC) activities
- Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
**Degree Requirements**
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
**Experience Requirements**
- 5+ years of experience in clinical science, clinical research, or equivalent
- Experience in driving, managing and collaborating in a team/matrix work environment
- Recognized internally and externally as a Therapeutic Area and Functional expert
**Key Competency Requirements**
- Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Ability to plan and manage
- Advanced ability to analyze, interpret, and present data
- Advanced knowledge and skills to support program specific data review, trend identification, data interpretation
- Advanced knowledge of indication, therapeutic area, compound(s), competitive landscape and health authority requirements
- Advanced medical writing and presentation skills
- Ability to self-supervise, and act independently to identify/resolve program level issues
- Proficient critical thinking, problem solving, decision making skills
- Effective planning and time management
- Advanced verbal, written and interpersonal skills (communication skills)
- Adaptable and analytical
- Strong presentation skills / leadership presence
- Commitment to Quality
- Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
- Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
**Travel Required**
Domestic and International travel may be required.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of com
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