Associate Director, Global Clinical Science - Neuroscience

Bristol Myers Squibb; Uxbridge; Remote; GBP 90,000 - 120,000; Full time

Job summary

Bristol Myers Squibb is seeking an experienced Clinical Trial Lead to oversee the implementation, planning, and execution of assigned clinical trial activities across one or more trials. You will provide scientific and clinical leadership to a team of Clinical Scientists and co-lead study team meetings with protocol partners.

In this role, you will collaborate with cross-functional teams, support development planning, and ensure high-quality data and regulatory documentation throughout trial

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.
• Excellent verbal, written, communication and interpersonal skills.
• Must be able to effectively communicate and collaborate across functions and job levels.

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 in collaboration with Medical Monitor/Clinical Development Lead.
• Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication of cross functional comments.
• Site-facing activities such as training and serving as primary contact for clinical questions.
• Data generation and validation activities including CRF design, data review, and query resolution.
• Clinical data trend identification and escalation of questions to Medical Monitor.
• Develop clinical narrative plan and review narratives.
• Provide information required for trial budgets, CRO scope of work, etc.
• Review development of site and CRA training materials and present at SIV/Investigator meetings.

Education

Life Sciences degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Electronic Data Capture (e.g., 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.

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 escalated 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 interpretationKnowledge 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 https://careers.bms.com/ways-of-working .

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