Executive Director, Head of Clinical Design & Delivery Center

Bristol Myers Squibb•Princeton, NJ

2d•$297,590 - $360,603•Remote

About The Position

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.

Requirements

Degree in Life Sciences (MD, PhD, PharmD, MS, RN, or other scientific field preferred) with a minimum of 10 years of experience in clinical development and the design and execution of clinical studies
Deep knowledge of regulatory and compliance requirements, clinical operations, statistics, and epidemiology
Deep understanding of early through late-stage drug development issues and challenges, as well as extensive experience with protocol development and review
Excellent problem-solving capabilities with ability to understand and simplify processes and interfaces between complex organizations.
Successful track record of leading through influence and working across complex, global organizational matrices
Change Agent - proven ability to lead during a time of significant change, and an ability to establish credibility and influence other executives through both formal and informal leadership
Drive for Results – track record of meaningful value creation and solution delivery through innovative ideas and agile execution; track record of developing goals and achieving business impact
Stakeholder Focus - exceptional capability to build alignment with senior level business partners and collaborate effectively with stakeholders and partners at the EVP/SVP/VP level
Talent Development - successful track record of building, leading and maintaining high-performing teams

Nice To Haves

If this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

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 PRC 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 portfolio decision-making, improve probability of technical success (PTS), and accelerate design and protocol development.
Partner with Data and Quantitative Sciences (DQS) leadership and Real World Data Research/IT to advance the use of real-world evidence and AI to inform trial design and improve PTS.
Support streamlining of the design and protocol development journey, including TA technical review and PRC review.
Collaborate with Global Quality and the Risk Based Management team to embed Quality by Design and critical to quality factors via protocol de-risking throughout the trial lifecycle.
Develop metrics to assess clinical development performance and identify actionable insights to inform process improvement (e.g., CDP/IADP and protocol development).
Serve as Global Process Owner for Protocol development within QMS network.
Incorporate outputs from enterprise initiatives into the development process (e.g., digital innovation, real-world capabilities, patient advocacy).
Evaluate industry-leading capabilities and support their implementation within BMS in a scalable fashion in support of clinical deliverables.
Lead the implementation of state-of-the-art AI and technology (e.g. FARO) to optimize clinical protocols; reduce patient/site burden, cost, and amendments; and accelerate downstream operational activities. Through active monitoring, ensure KPIs for innovative protocol and protocol process solutions are robust and meet/exceed business goals.
Evaluate cross-functional ways of working across the OneClinical model and support evolution of the model based on business needs.
Contribute to a high-performance culture by fostering innovation, collaboration, customer focus, personal accountability, and commitment to results.

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays each year
160 hours of paid vacation annually for new hires
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day