Senior Clinical Scientist, Early Clinical Development, Neuroscience

Bristol-Myers Squibb - Princeton, NJ

Full-time - Senior

Hybrid - Princeton, NJ

Chemical Manufacturing

About the position

The Senior Clinical Scientist in Early Clinical Development at Bristol Myers Squibb is responsible for the planning, implementation, and execution of clinical trial activities. This role involves leading multiple trials with minimal supervision, providing scientific and clinical leadership, and collaborating with various stakeholders to ensure high-quality clinical studies that contribute to the development of innovative therapies in neuroscience.

Responsibilities

• Maintain a thorough understanding of assigned protocols and educate team members.
• Plan and lead the implementation of clinical study startup, conduct, and close-out activities.
• Evaluate innovative trial designs in collaboration with the study physician.
• Manage protocol and ICF development process, ensuring high clinical quality in collaboration with Medical Writing.
• Serve as primary contact for site-facing activities, providing training and support for clinical questions.
• Conduct and oversee activities related to data generation and validation, ensuring consistent, quality data review.
• Identify clinical data trends and escalate questions to the study physician.
• Develop clinical narrative plans and review clinical narratives.
• Provide information required for the development of trial budgets and CRO scope of work.
• Review and develop site and CRA training materials and present at SIV and Investigator meetings.
• Author and review clinical study reports and clinical portions of regulatory documents.
• Collaborate and serve as primary liaison between external partners for scientific advice.
• Author and review abstracts, presentations, and manuscripts for external publications.

Requirements

• 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, and clinical operations.
• Proficient knowledge and skills to support program-specific data review, trend identification, and data interpretation.
• Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
• Excellent verbal, written, communication, and interpersonal skills.
• Ability to assimilate technical information quickly and take initiative.
• Detail-oriented with a strong sense of teamwork and 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.
• Proficient critical thinking, problem solving, and decision-making skills.
• Understanding of functional and cross-functional relationships.
• Commitment to Quality and adaptability to multiple demands.

Nice-to-haves

• Experience with Electronic Data Capture (e.g., RAVE) and data reporting tools.
• Familiarity with clinical trial management systems.

Benefits

• Competitive salary
• Comprehensive health insurance
• 401k retirement plan
• Flexible work environment
• Professional development opportunities
• Paid time off and holidays