Associate Director, Regulatory Excellence & Hematology/Oncology Operations

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. The 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. Key Responsibilities Serve as a strategic operational partner to the VP; develop leadership presentations, business reviews, and strategic planning materials that inform department priorities. Develop operational plans and lead the management cadence for the Onc/Hem regulatory team, including key leadership meetings, portfolio reviews, and planning cycles; ensure alignment, follow‑through, and compliance with governance expectations. Lead follow‑up on action items, critical deliverables, and leadership commitments; independently resolve or escalates highly complex issues and develop new options to address risks with broad impact on the department. Prepare governance materials, executive briefings, and decision‑ready content for senior leadership and cross‑functional forums. 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. Liaise with Global Regulatory Operations and project management teams to ensure alignment on submission timelines and deliverables. Lead the regulatory excellence agenda for the Onc/Hem TA by driving process improvement initiatives, establishing implementation plans, and ensuring progress is measured 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. Develop, update, and communicate standard operating procedures, work instructions, and best practice guides relevant to onc/hem regulatory operations. Coordinate training and onboarding activities for new team members. Support adoption of new regulatory tools and digital capabilities, including Veeva RIM, regulatory intelligence platforms, and AI‑assisted authoring tools. Coordinate cross‑functional relationships with Clinical Development, CMC, Medical Affairs, Commercial, Finance, and HR. Support coordination of cross‑functional regulatory workstreams and ensure clear communication of regulatory team needs and timelines to partner functions. Qualifications Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree (MSc, PhD, PharmD) preferred. 7–10 years of experience in business operations, program/project management, regulatory operations, or related roles within a complex, matrixed biopharmaceutical or healthcare environment. Experience leading cross‑functional initiatives of strategic importance. Demonstrated ability to lead complex projects, develop plans, lead meetings, and deliver outcomes with considerable independence. Recognized as an internal expert with strong judgment and credibility, representing the function on complex projects. 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 in a business operations or chief‑of‑staff type capacity. Preferred: experience in pharmaceutical, biotechnology, or healthcare environments. Preferred: familiarity with portfolio management, resource planning, or operational analytics. Preferred: experience with SharePoint, Planisware, Veeva, or similar platforms. Preferred: experience with global regulatory submissions (NDAs, BLAs, MAAs or equivalent) and health authority interactions. Preferred: exposure to process improvement methodologies such as Lean, Six Sigma. Functional Competencies Deep organizational awareness and ability to influence across matrixed environments. Strong leadership, execution, and follow‑through on strategic projects. Effective communication and stakeholder management. Ability to solve highly complex, sometimes novel problems with broad organizational impact. Collaboration across functions and levels. Anticipation of business and industry issues, adapting quickly, and contributing meaningful input to strategy development. Compensation Overview Princeton, NJ – US: $173,350 – $210,058 per year. Additional incentive cash and stock opportunities may be available based on eligibility. Final compensation will be decided based on demonstrated experience. Benefits Health coverage (medical, pharmacy, dental, vision); wellbeing support; retirement (401(k)); paid time off; flexible work arrangements; and other benefits as outlined on the careers site. Equal Employment Opportunity Visitcareers.bms.com/eeo-accessibility to view the full Equal Employment Opportunity statement. #J-18808-Ljbffr Bristol-Myers Squibb