Sr Clinical Scientist
vor 1 Tag
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.
**Position Responsibilities**
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
- Plan and lead the implementation all study startup/conduct/close-out activities as applicable
- Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)
- Protocol and ICF development process with mínimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
- Site-facing activities such as training and serving as primary contact for clinical questions
- Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
- Clinical data trend identification; provide trends and escalate questions to Medical Monitor
- Develop clinical narrative plan; review clinical narratives
- Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
- Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Collaborate and serve as primary liaison between external partners for scientific advice
**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
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
**Key Competency Requirements**
- Excellent verbal, written, communication and interpersonal skills
- Must be able to effectively communicate and collaborate across functions and job levels
- Ability to assimilate technical information quickly
- Routinely takes initiative
- Detail-oriented
- Strong sense of teamwork; ability to lead team activities
- Proficient in Medical Terminology and medical writing skills
- Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
- Proficient critical thinking, problem solving, decision making skills
- Understanding of functional and cross-functional relationships
- 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 competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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