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BeOne

Global oncology therapeutics discovery, development, manufacturing

Director – Global Digital & Technology Systems

Enterprise ApplicationsConfirmed live in the last 24 hours
Full-timeRemote in USA

About the Job

Requirements

  • At least 10 years of experience working on validated applications in a pharmaceutical or regulated environment, primarily clinical applications and/or systems management in the pharmaceutical or medical device industry, especially in CTMS, eTMF, IRT, EDC, and SSU management.
  • At least 8 years of experience working in a GxP or regulated environment with a strong understanding of SLC methodology, 21 CFR Part 11, and GAMP principles.
  • At least 5 years of proven senior-level leadership managing a team of direct reports and associate staff.
  • Proven experience overseeing the direction, planning, installation, implementation, and maintenance of software solutions, especially in SaaS or hybrid-cloud environments.
  • Good working knowledge of O365, Active Directory technology and schema, and SaaS-to-SaaS application integration frameworks.
  • Extensive experience in business and technical analysis, including developing requirements and translating them into data-driven and technical solutions.
  • Strong expertise in data management practices, including data integrity, accuracy, and reliability.
  • Significant experience delivering technical projects and managing multiple initiatives across diverse functions in a global environment.
  • Ability to quickly learn and adapt to several technology areas, with a proactive approach to industry trends and innovations.
  • Strong process-improvement skills and orientation.
  • Ability to communicate ideas in technical and user-friendly language.
  • Proven business and technology skills, with success providing customer-oriented technology solutions.
  • Bachelor's degree in Computer Science or Information Technology.
  • Ability to manage employees and contingent workers at global sites, including coaching and mentoring staff and providing training and professional development.
  • Effective leadership and communication skills, and ability to develop people while working across broad direct and matrixed relationships.
  • Understanding of pharmaceutical research and development, particularly the Clinical Operations function.
  • Comprehensive understanding of how AI solutions integrate within external systems and platforms, including machine-learning lifecycles, foundational models, and requirements for AI-ready data.
  • Ability to articulate the business value of external systems and platforms to clinical leadership and explain their strategic roadmap alignment with organizational goals.

Responsibilities

  • Own end-to-end lifecycle management for the portfolio of external systems and solutions used by Global Clinical Operations (GCO).
  • Oversee end-to-end management of GCO external systems.
  • Implement and deliver systems, applications, and projects that meet GCO business needs, including initiatives supporting GCO goals and objectives.
  • Provide data, digital, and technology systems expertise to GCO stakeholders for their domain-related needs.
  • Coordinate and drive system maintenance, including security patching, version upgrades, enhancements, and configuration changes to improve business processes, address gaps, enable automation, and support organizational growth.
  • Collaborate with GCO and GRDTS leadership to develop long-term strategies for external-system enhancements and technology investments.
  • Partner with stakeholders and subject matter experts to develop business cases that justify and prioritize system initiatives in alignment with the overall business plan.
  • Develop and manage budgets for external systems in alignment with organizational objectives and cost efficiency.
  • Ensure data integrity, security, and appropriate governance of information processed through external systems.
  • Coordinate and manage incident response for external-system issues, ensuring timely resolution and stakeholder communication.
  • Create and maintain documentation covering system architecture, functionality, and operational procedures.
  • Provide end-user guidance and support, and facilitate training to improve system utilization and productivity.
  • Identify risks associated with GCO external systems, establish mitigation strategies, and ensure regulatory compliance.
  • Engage and collaborate with third-party vendors, service providers, and stakeholders to manage contracts, performance, and service-level agreements.
  • Foster cross-functional collaboration to integrate clinical systems with corporate enterprise systems.
  • Collaborate with GRDTS capabilities and teams, including Technology & Systems Engineering and GRDTS Operations, to deliver solutions for GCO within allocated budgets.
  • Ensure GCO systems and data platforms comply with pharmaceutical industry regulations, internal functional and enterprise policies, and security policies.
  • Liaise with computer-system vendors, IT partners, audit, and compliance teams to coordinate system implementation and change activities.
  • Work within an operating model supporting current and future GCO technology needs, including requirements management, solutioning, build, implementation, and administration of global Development platforms, master data, and system interfaces.
  • Lead, mentor, and manage the GCO Systems Management team responsible for end-to-end lifecycle management of external GCO systems and platforms.
  • Foster a culture of innovation and accountability and drive professional development.
  • Ensure systems and platforms comply with pharmaceutical regulations and internal security policies.
  • Ensure the team is trained in and embeds CSV, compliance, and health-authority requirements into operational activities.
  • Collaborate with R&D functions and teams on standards and best practices to achieve business goals.
  • Engage with peers to define, sponsor, and execute continuous improvements.
  • Translate long-term clinical objectives into a multi-year system capability roadmap for external GCO systems.
  • Translate clinical workflows into structural, technical system, and data requirements.
  • Align clinical functions, internal IT groups, and external vendors around external-systems standards.
  • Oversee end-to-end delivery of digital and technology solutions, from initial scoping and vendor selection through deployment and value realization.
  • Develop the GCO data, digital, and technology roadmap for external systems, mapping technology solutions to clinical capability milestones.
  • Create business-capability maps of current and future technical capabilities across GCO and their relationships to other functions.
  • Produce detailed, prioritized product-requirements backlogs for the Systems Engineering team to integrate or enhance platforms.
  • Create conceptual design and specification documents for existing GCO platforms and systems and their interactions with other systems.
  • Prepare vendor-selection and proof-of-concept briefs, including formal evaluations, technical scores, and business cases for onboarding vendor platforms or specialized scientific AI tools.
  • Co-author platform operating models and governance structures with Systems Engineering and GTS to keep GCO platforms stable, highly available, and optimized in production.
  • Deliver and launch AOP projects based on approved requirements, specifications, development activities, and implementation plans.

Desired Qualifications

  • Working knowledge of IaaS, including Amazon Web Services and Azure, and PaaS and SaaS architectures and technology options.

About the Company

BeOne

Global oncology therapeutics discovery, development, manufacturing

BeOne Medicines discovers, develops, and commercializes oncology therapies worldwide, focusing on hematologic cancers and solid tumors. Its products work by leveraging internal R&D and clinical development to bring therapies to market quickly, with Brukinsa serving as a leading backbone in the US and European markets. It differentiates itself through a large-scale global clinical network and cost-efficient development and manufacturing that support high margins and a focus on large-market cancer indications. Its goal is to expand access to high-impact, affordable cancer treatments across more than 45 countries while growing its pipeline into immunology and solid tumors.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Dongcheng District, China
Founded
2010

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