Danielle Bell Email & Phone Number

Toronto, Ontario, Ca

Directed central support services for Trial Delivery organization to continuously optimize business operations strategy and ensure compliance and high-quality trial delivery. Served as core member of leadership team and Chief of Staff to Vice President.• Initiated and created framework for Business Operations Head role to deliver 1 strategy across all Therapeutic Areas (TAs), improving consistency in budget management, resource allocation, training, and onboarding.• Championed build-out and growth of business unit by adding 30 headcounts to support business operations, project management, CAPA management, resource planning / staffing, and vendor budget management, allowing trial leaders to work more efficiently.• Launched strategic initiatives that enhanced collaboration within and beyond department and with external vendor partners, ensuring alignment of key business priorities and annual goals.

Toronto, Ontario, Ca

Led cross-functional program teams and ensured deliverables were met for key operational milestones according to budget and timeline and with highest standard of quality.• Served as strategic operational advisor for Pediatric Portfolio within Immunology, overseeing multiple Global Trial Leaders across various compounds and disease areas to promote consistency and efficiency.• Designed and led cross-company Pediatric Center of Excellence, offering guidance to all teams, developing pediatric programs, and establishing standardized practices across all therapeutic areas.• Directed program team through successful FDA Sponsor Inspection, multiple FDA site inspections, Pharmaceuticals and Medical Devices Agency (PMDA) inspections for Japanese sites, and CRO, ensuring compliance and readiness for key registration program.

Toronto, Ontario, Ca

Demonstrated leadership and project management as lead Global Trial Leader responsible for start-up and executing pivotal Phase II/III Immunology Programs for in-house and outsourced studies.• Created Immunology Onboarding Checklist, orientation, and mentoring plan, streamlining onboarding process for new hires and supporting program leaders in effectively integrating new team members.• Developed External Service Provider Plan to standardize vendor partnership practices, confirming consistent oversight and management across diverse therapeutic areas.

Rahway, New Jersey, Us

Rahway, New Jersey, Us