Senior Director Risk Management and Central Monitoring

Bristol-Myers Squibb - Princeton, NJ

Full-time - Senior

Princeton, NJ

Chemical Manufacturing

About the position

The Senior Director, Risk Management and Central Monitoring position at Bristol Myers Squibb is a pivotal role within the Clinical Oversight and Risk Management Leadership Team. This position is responsible for developing and implementing risk-based strategies that enhance the efficiency and effectiveness of clinical trials through comprehensive monitoring and data oversight. The Senior Director will work closely with various stakeholders to ensure alignment and buy-in for the Risk-Based Management (RBM) strategy, which is crucial for delivering reliable clinical trial information necessary for internal decision-making, regulatory approval, and market acceptance. The role emphasizes a holistic approach to quality by design, clinical trial risk management, and continuous improvement, ensuring that the organization operates at the highest standards of quality and compliance. In this role, the Senior Director will lead the Risk Management and Central Monitoring team, guiding them in executing the RBM framework and enhancing quality across clinical trials (Phases 1-4). The position requires a strategic mindset to drive the development of a comprehensive vision and roadmap for risk management capabilities, enabling proactive risk management and data insights that support BMS Drug Development's performance and the safety of trial participants. The Senior Director will also be responsible for monitoring the quality of Global Development Operations (GDO) activities, identifying risks, and collaborating with various functions to address any gaps. The Senior Director will engage with VP-level peers across the Drug Development organization to facilitate risk discussions at the portfolio level, ensuring that insights from the Risk Management and Central Monitoring team inform decision-making at multiple levels, including site, study, and country. This role also involves participating in industry forums to stay abreast of best practices in centralized monitoring and risk management, ensuring that BMS remains at the forefront of industry standards. The position is expected to be in the office 50% of the time over a two-week period, in accordance with company policy.

Responsibilities

• Drive the development and delivery of the vision, strategy, and roadmap for Risk Management and Central Monitoring in partnership with the Clinical Oversight and Risk Management Leadership Team.
• Lead and shape the Risk Management and Central Monitoring team to execute the Risk Based Management Framework and enhance quality across clinical trials.
• Manage governance for ongoing review of portfolio risk to support successful delivery of portfolio priorities for specific therapeutic areas.
• Implement an effective quality by design and risk-based management approach across clinical trials.
• Monitor the holistic quality of Global Development Operations activities, identifying risks and supporting functions to remediate gaps.
• Act as the GDO point of contact for quality oversight in RBM implementation, driving best practices for clinical trials.
• Identify and escalate significant operational, quality, and compliance risks within the established risk management framework.
• Develop strong working relationships with key stakeholders throughout BMS and influence peers and senior management effectively.
• Collaborate with Global Development Operations, Quality Assurance, and process owners to ensure processes meet organizational and regulatory needs.
• Provide leadership and oversight to the Risk Management and Central Monitoring process and audits, ensuring quality readiness for regulatory inspections.
• Develop and implement strategies to incorporate automation and emerging technologies for risk identification and management.
• Provide ongoing feedback, coaching, and career development support to staff to maximize their potential and performance.
• Promote a workplace culture that values diversity of thought, integrity, and accountability.

Requirements

• A minimum of a Bachelor's degree (or equivalent degree) is required; a degree in life science, natural science, or business is preferred.
• Broad knowledge of global drug development processes is required, with at least 10 years of GCP-related experience in clinical operations.
• Relevant therapeutic area experience is necessary to shape thinking and strategy.
• Inspection experience is a plus.
• Experience in centralized monitoring and risk management in a regulated industry is required.
• Enterprise Risk Management knowledge is preferred.
• Experience in managing diverse teams and operating in a matrix organization is essential.
• Engagement in industry-leading forums related to risk management and central monitoring is expected.
• Demonstrated ability to adopt a biopharma enterprise-wide mindset, acting with speed, accountability, and integrity.
• Proven team and matrix leadership skills, with the ability to align with enterprise and senior leadership.

Nice-to-haves

• Knowledge of external health authority and industry trends and emerging areas of interest.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health insurance coverage.
• Retirement savings plan with 401(k) options.
• Flexible work arrangements and hybrid work model.
• Opportunities for professional development and career growth.
• Employee wellness programs and resources.