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.
• 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.
• 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.

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