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 Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
Position Summary / Objective
- Responsible for implementation, planning, and execution of assigned clinical trial activities.
- Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision.
- Provides scientific and clinical leadership to clinical scientists on study team (matrix leadership).
- May support clinical development planning in collaboration with Early Clinical Development physician(s).
- Maintain a thorough understanding of assigned protocols and protocol requirements and educate team members.
- Plan and lead the implementation of clinical study startup/conduct/close-out activities as applicable.
- Evaluate innovative trial designs in collaboration with the study physician.
- Manage protocol and ICF development process (e.g., documents and amendments) with minimal guidance; includes writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing. Present to governance committee and early clinical development team meetings as required.
- Serve as primary contact for site-facing activities such as training and support for clinical questions.
- Conduct and oversee activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review.
- Identify clinical data trends; provide trends and escalate questions to study physician.
- Develop clinical narrative plan and review clinical narratives.
- Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Review/develop site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., safety review) activities.
- Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses).
- Collaborate and serve as primary liaison between external partners for scientific advice.
- Author/review abstracts, presentations, and manuscripts for external publications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
- 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.
- Strong sense of teamwork; ability to lead matrix 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.