Associate Director, Global Clinical Science Neuroscience

At Bristol Myers Squibb our employees often ask Who are you working fora 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 doesnt 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 People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit 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.

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