Global Clinical Science Lead - Trials & Strategy

Bristol-Myers Squibb; Madison (NJ); On-site; USD 184,000 - 257,000; Full time

Job summary

Bristol Myers Squibb is seeking a Clinical Trial Lead to drive planning and execution across one or more trials in a dynamic, collaborative environment in Madison, NJ. You will provide scientific leadership to a team and partner with cross-functional study members to advance trials from startup through close-out.

The role requires 5+ years in clinical science, strong GCP/ICH knowledge, and expertise in data review, interpretation, and medical writing.

Qualifications

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other 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

Responsibilities

• Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
• Plan and lead the implementation of 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 minimal guidance; writing, reviewing, adjudication of cross functional comments and ensuring high clinical quality
• Site-facing activities such as training and serving as primary contact for clinical questions
• Data generation and validation, including CRF design, clinical data review/query resolution; ensure data quality
• Clinical data trend identification; provide trends and escalated questions to Medical Monitor
• Drafting/review and validation of CSRs and regulatory documents; collaborate with external partners

Skills

Clinical trial leadership

Cross-functional collaboration

GCP/ICH knowledge

Data review/analysis

Medical writing

Education

Life Sciences degree

Tools

RAVE

J-Review

Job description

Bristol Myers Squibb is seeking a Clinical Trial Lead to drive planning and execution across one or more trials in a dynamic, collaborative environment in Madison, NJ. You will provide scientific leadership to a team and partner with cross-functional study members to advance trials from startup through close-out.

The role requires 5+ years in clinical science, strong GCP/ICH knowledge, and expertise in data review, interpretation, and medical writing.