Executive Director, Head of Clinical Design & Delivery Center

Bristol Myers Squibb; Princeton (NJ); On-site; USD 180,000 - 300,000; Full time

Job summary

Bristol-Myers Squibb in Princeton, NJ seeks an Executive Director, Clinical Design and Delivery Center (CDDC) to provide strategic leadership of the Protocol Management Office (PMO) and governance for protocol review, SAPs, and DMC charters across the portfolio.

The role will drive education initiatives to strengthen clinical development capabilities, ensure quality and regulatory compliance, and represent BMS in industry forums to promote process excellence and innovation in development.

Qualifications

• Must lead with strategic vision across global clinical development programs.
• Strong ability to manage cross-functional teams and complex programs.

Responsibilities

• Lead Protocol Management Office (PMO) for review of protocols, SAPs, DMC charters, and related documents across the portfolio.
• Provide rigorous scientific review and revision to pivotal protocols/documents across therapeutic areas.
• Oversee a team coordinating reviews across all therapeutic areas and align resources accordingly.
• Liaise with senior stakeholders (e.g., TA heads) to ensure quality and address issues during PRC review.
• Develop and refine processes for protocol/document submission and triage criteria.
• Create, implement, and maintain an integrated, compliant system for storing and retrieving PMO materials and decisions.
• Develop metrics to track outputs and identify continuous improvement opportunities.
• Lead educational/training programs to advance clinical development capabilities and collaborate with BMS Learning.

Skills

Strategic leadership

Stakeholder management

Clinical development expertise

Quality/compliance mindset

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

The Executive Director, Clinical Design and Delivery Center (CDDC), will provide strategic leadership and oversight of the Protocol Management Office (PMO), which is responsible for the comprehensive review of clinical protocols, statistical analysis plans (SAPs), Data Monitoring Committee (DMC) charters, and other critical study documents across the BMS portfolio to ensure the highest standards of scientific rigor and quality.

The Executive Director will play a key role in the design, development, and delivery of educational and training initiatives aimed at strengthening clinical development capabilities and advancing the expertise of clinical physicians and scientists across the organization. In addition, this individual will lead and support strategic initiatives focused on enhancing innovation, operational excellence, and efficiency within clinical development, while serving as a trusted advisor on quality, compliance, and process-related matters throughout the development organization.

The Executive Director will contribute to the ongoing evolution and execution of the CDDC strategic roadmap, ensuring alignment with business priorities, organizational objectives, and emerging industry trends. Furthermore, this individual will represent BMS externally through active engagement in industry forums, conferences, and professional roundtables, promoting thought leadership in clinical development process excellence. By maintaining a strong awareness of the evolving external landscape, the Executive Director will help incorporate industry best practices and insights into the CDDC strategy, further strengthening BMS's reputation and leadership within the clinical development community.

Responsibilities

• Lead a Protocol Management Office (PMO) responsible for the review of protocols, SAPs, DMC charters, and other key documents/plans across the BMS portfolio to ensure outputs with high scientific quality.
• Provide rigorous scientific review, commentary, and revision to pivotal protocols/documents across all BMS therapeutic areas (TAs) to ensure they meet appropriate levels of scientific quality.
• Oversee a team that coordinates review activities across all BMS TAs and ensure resources are aligned with requisite activities.
• Liaise with senior stakeholders (e.g., TA heads within Drug Development) in furthering the scientific quality of outputs and addressing issues that arise during PRC review. Support PRC leaders within the TAs to drive consistent review processes.
• Ensure review processes lead to high-quality, scientifically rigorous, and feasible studies that meet regulatory/compliance standards.
• Develop and refine processes for protocol/document submission and associated triage criteria.
• Integrate protocol and document review processes into overarching governance processes.
• Create, implement, and maintain an integrated, organized, compliant system for storing and retrieving P RC materials, meeting outputs, and decisions taken.
• Develop metrics and indicators to track outputs and trends associated with protocol development and identify areas of continuous improvement.
• Incorporate state-of-the-art advances related to protocol development/study design and associated review based on internal and external insights from industry, regulators, and other bodies.
• Lead the development and delivery of educational and training programs focused on advancing clinical development capabilities.
• Oversee efforts to develop and deliver educational and training materials in coordination with BMS Learning, with an intended audience of clinical physicians and scientists.
• Contribute to a best practices hub focused on enhancing clinical development innovation, execution, and delivery.
• Help nurture a community of practitioners that optimizes collaboration through internal knowledge sharing to enhance the organization's clinical development skills and capabilities.
• Lead initiatives focused on enhancing clinical development innovation and efficiency.
• Oversee a group focused on developing, enhancing, maintaining, and measuring the effectiveness/compliance of clinical processes, including but not limited to: study designs, protocol optimization, protocol development/authoring, protocol deviations, clinical development team (CDT) operating model.
• Contribute to processes for the Clinical Development Plan (CDP)/Integrated Asset Development Plan (IADP) to facilitate early-to-late development transition, support portfo