Director, US Head of HOCT Trial Management, Clinical Operations

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.

Position Summary

The Director of Clinical Operations is accountable for the delivery of all clinical trials for their assigned therapeutic area. The individual leads the HOCT Clinical Trial Management team for Regional Clinical Operations, North America, and is responsible for ensuring the effective execution of clinical trials across the BMS R&D portfolio.

Reporting to the Regional Head of Clinical Operations, this role is a key member of the RCO and GDO extended leadership teams, as well as serving as a member of the local affiliate leadership team and affiliate leadership committees (where applicable).

Key Responsibilities

• Provide strategic and operational direction for clinical trial execution at the country level across all development phases, ensuring delivery against timelines, quality standards, and budget targets
• Adopt an enterprise perspective to decision making, considering the benefits to the wider organization in addition to the cluster/function, and support BMS to maintain a competitive industry advantage
• Lead internal communication and alignment within the affiliate regarding BMS clinical trial strategy
• Lead a team of Clinical Operations professionals, including direct supervision of oversight of Line Managers, Clinical Trial Managers (CTMs) and Country Coordinators (CCs)
• Build, lead, and sustain a high-performing team through strategic hiring, performance management, succession planning, and ongoing coaching and development, actively engaging team members to maximize potential and support talent retention
• Develop and promote a workplace culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability
• Strategically assess demand and priorities within the cluster, ensuring resource optimization of the team to deliver to committed/validated clinical trial targets and performance metrics; where needed, initiate appropriate actions in response to changes in priorities
• Set goals for the cluster, including ongoing evaluation of progress against committed clinical trial milestones
• Approve key operational delivery elements for the cluster, including country site and enrollment targets
• Approve study fee funds and payments based on grant of authority
• Maintain a thorough understanding of the local regulatory environment within the region, providing direction and guidance to support optimal trial delivery
• Provide support during preparation and conduct of quality audits and regulatory inspections
• Support the development and implementation of Corrective and Preventative Actions (CAPA) for local issues, ensuring the necessary resources and tools are available
• Develop and maintain productive working relationships with key cross-functional stakeholders, with the ability to leverage insights, effectively express views, and influence different levels of the organization
• Function as a key point of contact for FSP staff, ensuring alignment with operational and strategic priorities
• Represent the company in interactions with key external partners including industry bodies, investigators and site staff, and local authorities
• Represents RCO and GDO within affiliate-level leadership discussions
• Effectively manage situations involving conflict resolution, problem-solving, and crisis management
• Support the proactive identification of improvement areas and contribute to continuous refinement of processes, systems, and strategies to support the ongoing evolution of RCO and GDO
• Contribute to global, regional, and country-level initiatives to ensure regional considerations and operational implications are captured and considered

Qualification & Experience

• Bachelor’s degree required with an advanced degree preferred
• Extensive relevant industry experience, with experience in the management of staff in a pharmaceutical and/or biotechnology environment
• Significant experience in the delivery of global clinical trials in a variety of operating models (internal and outsourced delivery); with proven success in the delivery of clinical operations and the ability to translate science into robust operational delivery plans
• A strong understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena
• Knowledgeable of global regulatory requirements and ICH GCP principles as they relate to clinical trial execution and impact to the business supporting clinical trial execution

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