Position Summary

Bristol Myers Squibb is seeking an Associate Director, Regulatory Excellence & Hematology/Oncology Operations to lead operational and business management activities within the Oncology/Hematology organization. This role serves as a strategic partner to leadership, driving execution of portfolio priorities, operational planning, compliance, and regulatory excellence initiatives across a team of approximately 45 professionals.

The successful candidate will be recognized internally as a subject matter expert in regulatory operations and business management, exercising considerable latitude in shaping deliverables, leading initiatives of strategic importance, and developing solutions to highly complex, sometimes novel problems with broad impact across the department. The role requires anticipating business and industry trends, representing BMS with key internal and external partners, and ensuring effective planning, meeting leadership, and compliant execution across a matrixed environment.

Key Responsibilities

Operational & Leadership Support

• Serve as a strategic operational partner to the VP, leading development of leadership presentations, business reviews, team communications, and strategic planning materials that inform department priorities and decision-making
• Develop operational plans and lead the management cadence for the Onc/Hem Regulatory team, including key leadership meetings, portfolio reviews, and planning cycles, ensuring alignment, follow-through, and compliance with governance expectations
• Lead follow-up on action items, critical deliverables, and leadership commitments, independently resolving or escalating highly complex issues and developing new options to address risks with broad impact on the department
• Lead preparation of governance materials, executive briefings, and decision-ready content for senior leadership and cross-functional forums, exercising considerable latitude in determining objectives, framing recommendations, and shaping deliverables
• Actively identifies organizational risks to the VP in a timely manner and leads mitigation

Regulatory Portfolio Coordination & Tracking

• Maintain and update portfolio-level tracking tools, dashboards, and milestone reports to provide leadership with visibility into submission timelines, regulatory commitments, and program status
• Coordinate cross-team information gathering to support portfolio reviews, resource discussions, and pipeline updates
• Partner with Regulatory Team Leaders and program teams to monitor and communicate key regulatory milestones, flagging risks or delays proactively
• Support resource tracking and workload monitoring across the Onc/Hem Regulatory group to assist leadership in allocation decisions
• Liaise with Global Regulatory Operations and project management teams to ensure alignment on submission timelines and deliverables

Regulatory Excellence & Process Improvement

• Lead the Regulatory Excellence agenda for the Onc/Hem TA by driving process improvement initiatives of strategic importance, establishing implementation plans, and ensuring progress is measured, communicated, and sustained
• Identify systemic workflow inefficiencies and develop new approaches to solve highly complex, sometimes novel operational problems that affect team performance, submission quality, and departmental effectiveness
• Help develop, update, and communicate standard operating procedures (SOPs), work instructions, and best practice guides relevant to Onc/Hem regulatory operations
• Coordinate training and onboarding activities for new team members, ensuring smooth integration into team processes, systems, and culture
• Support adoption of new regulatory tools and digital capabilities including Veeva RIM, regulatory intelligence platforms, and AI-assisted authoring tools
• Benchmark regulatory performance, monitor emerging business and industry trends, and provide input into strategy development to strengthen regulatory operations, digital adoption, and organizational effectiveness

Team & Organizational Effectiveness

• Support the VP and Team Leaders with team engagement initiatives, logistics for team events, off-sites, and recognition programs
• Coordinate onboarding plans for new hires across the Onc/Hem Regulatory team, partnering with HR and IT to ensure readiness on Day 1
• Help maintain and update organizational charts, team rosters, and role descriptions as the team evolves
• Assist with performance cycle coordination including timeline tracking, calibration logistics, and goal-setting reminders
• Serve as a culture ambassador, helping to reinforce team values, inclusion efforts, and engagement across a hybrid/distributed team

Cross-Functional Coordination

• Build and lead relationships with key partners in Clinical Development, CMC, Medical Affairs, Commercial, Finance, and HR, and represent BMS as a primary operational and technical contact for designated cross-functional initiatives, contracts, or projects
• Support coordination of cross-functional regulatory workstreams and ensure clear communication of regulatory team needs and timelines to partner functions
• Help prepare the Onc/Hem Regulatory team's inputs for enterprise-level regulatory operations initiatives and BMS-wide programs
• Serve as a point of contact for administrative and operational inquiries directed at VP

Qualifications

Required

• Bachelor's degree in Life Sciences, Pharmacy, or a related field; advanced degree (MSc, PhD, PharmD) preferred
• Minimum 7–10 years of experience in business operations, program/project management, regulatory operations, or related roles within a complex, matrixed biopharmaceutical or healthcare environment, including experience leading cross-functional initiatives of strategic importance
• Demonstrated ability to lead complex projects, develop plans, lead meetings, and deliver outcomes with considerable independence in a fast-paced, highly matrixed environment
• Recognized as an internal expert in own field, with strong judgment, credibility, and the ability to represent the function as a primary contact on complex projects or cross-functional initiatives
• Excellent written and verbal communication skills
• Proficiency in Microsoft Office Suite (PowerPoint, Excel, Word, Teams)
• Ability to work effectively in a fast-paced, dynamic environment

Preferred

• Experience supporting senior leaders or working in a business operations or chief of staff–type capacity
• Experience in pharmaceutical, biotechnology, or healthcare environments
• Familiarity with portfolio management, resource planning, or operational analytics
• Experience with tools such as SharePoint, Planisware, Veeva, or similar platforms
• Experience with global regulatory submissions (NDAs, BLAs, MAAs or equivalent) and health authority interactions
• Exposure to process improvement methodologies (e.g., Lean, Six Sigma)

Functional Competencies

• Deep organizational awareness and the ability to influence across matrixed environments with credibility as a recognized expert
• Strong leadership, execution, and follow-through on projects and initiatives of strategic importance
• Effective communication and stakeholder management
• Ability to solve highly complex, sometimes novel problems by developing practical options and recommendations with broad organizational impact
• Collaboration across functions and levels
• Ability to anticipate business and industry issues, adapt quickly, and contribute meaningful input to strategy development