Senior Director Risk Management and Central Monitoring

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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Position Summary

Senior Director, Risk Management and Central Monitoring Position is a critical member of the Clinical Oversight and Risk Management Leadership Team and accountable to develop and drive Risk Based strategies to enable the efficient and effective execution of clinical trials through monitoring and data oversight. Key strategic and tactical activities include the execution of the strategic vision for the organization, and to enable a highly efficient and engaged organization through operational directives and key initiatives.

The role is accountable for defining the RBM strategy, collaborating with stakeholders to ensure buy in and leading the Risk Management and Central Monitoring team, responsible for supporting delivery of reliable clinical trial information for internal decision making, regulatory approval and market acceptance, and ensure a holistic community of practice centered on quality by design, clinical trial risk management, efficient issue management, and continuous improvement.

The role will need to play an instrumental role in collaborating and negotiating with VP level peers in the broader Drug Development organization to facilitate risk discussion at portfolio level and would operate for a specific TA The insights that come from the RM_CM TA specific team will be used for decision making at site, study, country, portfolio level.  

The Senior Director, Risk Management and Central Monitoring, is an industry thought leaders and seeks understanding of what industry best practice is and is engaged in industry leading forums for bringing industry standards in centralized monitoring into BMS.

This role is expected to be in office 50% of the time over 2 weeks per company policy.

Key Responsibilities
- Drive the development of and deliver the vision, strategy and road map, in partnership with the CORM LT, to build a holistic and integrated Risk Management and Central Monitoring capability and processes to drive proactive risk-based management and related data insights that enable BMS Drug Development to accelerate in performance and safeguarding the well-being of our trial participants.

- Lead and shape the Risk Management and Central Monitoring TA specific team, enabling them to lead execution of the Risk Based Management Framework, enhancement of quality, compliance and inspection readiness across the clinical trials (Phase 1-4) in the portfolio.

- Lead and manage governance for ongoing review of portfolio risk to support successful delivery of  

portfolio priorities for specific TA

-Is accountable for implementing an effective quality by design and risk-based management approach.

- Accountable for monitoring holistic quality of GDO activities across the portfolio, identifying risks and supporting functions to remediate gaps.

-GDO point of contact for Quality oversight in RBM implementation, driving best practice and improved quality for clinical trials

- Seeks understanding of what industry best practice is and is engaged in industry leading forums for bringing industry standards in centralized monitoring into BMS.

-Accountable for the identification and/or escalations of significant operational, quality and compliance risks within established risk management framework and councils. Participates in investigations and mitigation measures.

- Develops strong and productive working relationships with key stakeholders throughout BMS, demonstrates the ability to think strategically across R&D, and effectively influence peers and senior management.

- Collaborates with Global Development Operations, Quality Assurance, and process owners to ensure that processes, SOPs, oversight, and governance meet the nee