Associate Director, Global Clinical Science - Neuroscience

Job title: Associate Director, Global Clinical Science - Neuroscience

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.

Summary

• 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 escalate questions to Medical Monitor
• Develop clinical narrative plan; review clinical narratives
• Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
• 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

Requirements

• 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

• 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

• 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

• 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.

• How We Work

• Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at

• Supporting People with Disabilities

• BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

• Bristol Myers Squibb is Disability Confident – Employer

• A UK Government scheme

• Candidate Rights

• BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

• Data Protection

• We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

• Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

• If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

• R1607467 : Associate Director, Global Clinical Science - Neuroscience