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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Director, US Head of HOCT Trial Management - Clinical Operations

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timePrinceton, NJ, USAIn-person

About the Job

Requirements

  • A bachelor's degree is required; an advanced degree is preferred.
  • Extensive relevant industry experience, including staff management experience in a pharmaceutical and/or biotechnology environment.
  • Significant experience delivering global clinical trials in a variety of operating models, including internal and outsourced delivery, with a proven record in clinical operations and translating science into operational delivery plans.
  • Strong understanding of the drug development process and proven expertise in global clinical trial execution and management.
  • Knowledge of global regulatory requirements and ICH Good Clinical Practice principles as they relate to clinical trial execution and its business impact.
  • Extensive understanding and experience of the environment in the assigned territory.

Responsibilities

  • Provide strategic and operational direction for country-level clinical trial execution across development phases, ensuring delivery against timelines, quality standards, and budget targets.
  • Make decisions from an enterprise perspective, considering benefits to the wider organization and supporting BMS's competitive advantage.
  • Lead internal affiliate communication and alignment regarding BMS clinical trial strategy.
  • Lead a Clinical Operations team, including direct supervision and oversight of Line Managers, Clinical Trial Managers, and Country Coordinators.
  • Build and sustain a high-performing team through strategic hiring, performance management, succession planning, coaching, and development; engage team members to maximize potential and support retention.
  • Develop a workplace culture that values diversity of thought and integrity, and supports coaching and accountability.
  • Assess cluster demand and priorities, optimize team resources against clinical trial targets and performance metrics, and initiate actions when priorities change.
  • Set cluster goals and evaluate progress against committed clinical trial milestones.
  • Approve cluster operational delivery elements, including country site and enrollment targets.
  • Approve study fee funds and payments within the grant of authority.
  • Maintain understanding of the local regulatory environment and provide direction and guidance for effective trial delivery.
  • Support preparation for and conduct of quality audits and regulatory inspections.
  • Support development and implementation of Corrective and Preventative Actions for local issues, ensuring necessary resources and tools are available.
  • Develop productive relationships with cross-functional stakeholders, leverage insights, express views, and influence across organizational levels.
  • Serve as a key point of contact for FSP staff and align their work with operational and strategic priorities.
  • Represent the company with external partners, including industry bodies, investigators, site staff, and local authorities.
  • Represent RCO and GDO in affiliate-level leadership discussions.
  • Manage conflict resolution, problem-solving, and crisis situations.
  • Identify improvement opportunities and contribute to ongoing refinement of RCO and GDO processes, systems, and strategies.
  • Contribute to global, regional, and country-level initiatives to incorporate regional considerations and operational implications.

Desired Qualifications

  • An advanced degree.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

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