Director, Global Digital & Technology Systems

BeiGene; United States; Remote; USD 173,000 - 233,000; Full time

Job summary

BeOne Medicines is seeking a seasoned Digital & Technology Systems Director to own the end-to-end lifecycle management of external GCO applications and platforms. The role requires strong leadership, cross-functional collaboration, and a deep understanding of regulated clinical systems in a cloud/SaaS environment.

The ideal candidate will lead strategy, security, and financial governance across global teams, ensuring compliance with CSV and 21 CFR Part 11 while delivering scalable, high-quality

Qualifications

• 10+ years of experience working on validated applications in a pharmaceutical or regulated environment, primarily clinical applications and/or systems management.
• 8+ years in a GxP or regulated environment with SLC, 21CFR Part 11, GAMP.
• 5+ years leading a team of direct reports and staff.
• Overseeing direction, planning, installation, implementation, and maintenance of software solutions in SaaS/Hybrid cloud.
• Strong knowledge of data management, data integrity, and data reliability.

Responsibilities

• Accountable for lifecycle management of all external GCO applications and platforms.
• End-to-end system management and oversight of all GCO external systems.
• Collaborate with GRDTS capabilities and teams within budget to deliver GCO solutions.
• Ensure GCO systems comply with pharmaceutical regulations and internal security policies.
• Lead and mentor a high-performing GCO Systems Management team and drive professional development.
• Coordinate with vendors, IT partners, audit and compliance for system changes.

Skills

Leadership

Clinical IT

SaaS/Hybrid cloud

Regulated environment

CSV/compliance

Data management

Vendor management

IaaS/PaaS/SaaS

Stakeholder collaboration

Project management

Education

Bachelor's Degree in Computer Science or Information Technology

Tools

O365

Active Directory

AWS

Azure

SaaS integration framework

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

BeOne Medicines Global Research and Development Technology Solutions (GRDTS) team is seeking a motivated, enthusiastic, and experienced Digital & Technology Systems Director to join our Development Technology team. The director, Global Digital & Technology Systems will own the end-to-end system management life cycle of the portfolio of external systems and solutions used by the Global Clinical Operations (GCO) function at BeOne.

The ideal candidate should bring deep knowledge of the clinical space and experience working in Cloud/SaaS environments with the ability to manage multiple projects across different functions in a global, geographically diverse environment. The candidate should also be experienced at running technology projects from a strategy, technology, security, process, finance, and people management standpoint. As a system owner, the individual must demonstrate a strong understanding of system lifecycle management and be able to provide technical expertise while guiding system administration activities. Additionally, they should be adept at fostering collaboration among stakeholders to ensure the system aligns with organizational goals and meets regulatory requirements.

Essential Functions of the Job:

• Accountable for the entire lifecycle management of all external Global Clinical Operations (GCO) applications and platforms.

• Responsible for end-to-end system management and oversight of all GCO external systems:

Collaboration within GRDTS:

• Collaborate with other GRDTS capabilities & teams, including Technology & Systems Engineering, GRDTS Operations to deliver solutions for the GCO function within allocated budgets.

• Ensure all GCO-related systems and data platforms adhere to relevant pharmaceutical industry regulations and internal functional & Enterprisepolicies including security policies.

• Liaise with computer system vendors, IT partners, audit, and compliance to coordinate system implementation and change activities.

• Work within a framework and operating model that supports the current and future technology needs for GCO, that comprises requirements management, solutioning, build, implementation, and administration (run) of global Development platforms, master data, and system interfaces

GRDTS GCO Systems Management Team Leadership:

Team Leadership & Talent Development:

• Lead, mentor, and manage a high-performingGCO Systems Managementteamfocused on end-to-end system lifecycle management for all external GCO systems and platforms.

• Foster a culture ofinnovation,accountabilityand drive professional development.

Operational Excellence, Compliance & Governance:

• Ensure all systems and platforms adhere to relevantpharmaceutical industry regulationsand internal security policies.

• Liaise with vendors,EnterpriseIT partners, audit, and compliance to coordinate system implementation and change activities

• Ensuretheteam is trained in and embeds CSV, compliance, and health authority requirements into operational activities.

Collaboration &Partnership:

• CollaboratewithR&D functions and teams on standards and best practicestoattain business goals

• Engage with peers to define, sponsor, and execute continuous improvements.

Qualifications:

• 10+ years of experience working on validated applications in a pharmaceutical or regulated environment, primarily clinical applications and/or systems management in a pharmaceutical or medical device industry especially in CTMS, eTMF, IRT, EDC, SSU management.

• 8+ years of experience working in a GxP or regulated environment with a strong understanding of SLC methodology, 21CFR Part 11 and GAMP principles.

• 5+ years of proven leadership at a senior level managing a team of direct reports and associate staff

• Proven experience in overseeing the direction, planning, installation, implementation, and maintenance of software solutions especially in the SaaS/Hybrid cloud environment.

• Good working knowledge of O365, active directory technology and schema, and SaaS to SaaS application integration framework.

• Working knowledge of IaaS (Amazon Web Services, Azure) PaaS and SaaS architectures and technology options a plus.

• 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, demonstrating a proactive approach to industry trends and innovations

Supervisory Responsibilities:

Manage team members (employees and contingent workers) at global sites, including coaching and mentoring of staff with training and professional development.

Must be an effective leader and communicator and considered to be a developer of people comfortable working with a broad cross-section of people in direct and matrixed relationships.

Key Capabilities

• Strategic System Roadmap: Translating long-term clinical objectives into a multi-year system capability roadmap for external GCO systems.

• Clinical & Technical Translation: Fluency in “clinical domain speak” related to GCO to accurately translate complex clinical workflows into structural, technical system and data requirements.

• Stakeholder Orchestration & Influence: Navigating a matrixed environment to align with various clinical functions, internal IT groups, and external vendors around external systems standards.

• Solution Lifecycle Oversight: Managing the end-to-end delivery of digital & technology systems & solutions—from initial scoping and vendor selection through deployment and value realization.

Key Competencies

• Pharma Industry R&D Domain Literacy: Understanding of the pharmaceutical research and development value chain, mainly for the Clinical Operations function.

• AI & Data Literacy: Comprehensive understanding of how AI solutions integrate within external systems and platforms, including knowledge of machine learning lifecycles, foundational models, and the requirements for “AI-ready data” to ensure effective clinical systems implementations and management.

• Strategic Communication: Ability to articulate the business value proposition of external systems and platforms to clinical leadership, helping them understand the strategic roadmap and how the platform aligns with organizational goals and objectives

Key Deliverables

• GCO function Data, Digital, & Technology Roadmap for external systems: Short-term and long-term strategic blueprint mapping technology solutions directly to clinical capability milestones.

• Business Capability Maps: Visual matrices mapping out current-state vs. future-state technical capabilities across GCO, and relationships to other functions.

• Product Requirements Documents (PRDs): Detailed, prioritized functional and technical requirement backlogs that can be used by the Systems Engineering team to integrate or enhance platforms.

• Conceptual design & specification documents for existing GCO platforms & systems and its interactions with other systems.

• Vendor Selection & Proof-of-Concept (PoC) Briefs: Formal evaluations, technical scores, and business cases for onboarding specialized vendor platforms or niche scientific AI tools.

• Platform Operating Models: Governance structures co-authored with the Systems Engineering capability & GTS to ensure GCO platforms remain stable, highly available, and optimized during production runs.

• Delivery & launch of AOP projects based on approved requirements, specifications, development activities & implementation plans.

Other Qualifications:

• Strong process improvement skills and orientation.

• Ability to communicate ideas in both technical and user-friendly language.

• Must have proven business and technology skills, with success providing customer-oriented technology solutions environment.

Travel:

• < 15%

Education Required:

• Bachelor’s Degree in Computer Science or Information Technology

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork

• Provides and Solicits Honest and Actionable Feedback

• Self-Awareness

• Acts Inclusively

• Demonstrates Initiative

• Entrepreneurial Mindset

• Continuous Learning

• Embraces Change

• Results-Oriented

• Analytical Thinking/Data Analysis

• Financial Excellence

• Communicates with Clarity

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $172,500.00 - $232,500.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].