Associate Director, Global Clinical Science - Neuroscience

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

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary / Objective

• Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials
• Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision
• Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)
• Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members
• May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)

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 minimal 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 escalated questions to Medical Monitor
• 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.

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

• Cambridge Crossing: $211,910 - $256,789
• Madison - Giralda - NJ - US: $184,270 - $223,294