Senior Clinical Scientist, Early Clinical Development, Neuroscience

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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.

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). Position Responsibilities

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. 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. Reporting Relationship

Report to Director, Clinical Scientists, Early Development. Degree Requirements

Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar 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 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. Travel Required

Domestic and international travel may be required (approximately 10-25%).

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