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:
- Implementation and delivery of systems/applications and projects that meet GCO business needs, including key initiatives to support GCO goals and objectives.
- Provide data, digital, and technology systems expertise to GCO stakeholders for their domain related needs.
- Coordinate and drive system maintenance such as security patching, version upgrades, enhancements and configuration changes focused on improving business processes, addressing gaps, and enabling automation and organizational growth.
- Collaborate with GCO and GRDTS leadership to develop long-term strategies for external systems enhancements and technology investments.
- Partner with stakeholders and subject matter experts (SMEs) to develop business cases that justify and prioritize system initiatives, ensuring alignment with the overall business plan.
- Develop and manage budget around external systems ensuring alignment with organization objectives and cost-efficiency.
- Ensure data integrity, security, and proper governance of information processed through external systems.
- Coordinate and manage incident response for external system issues, ensuring timely resolution and communication with stakeholders.
- Create and maintain comprehensive documentation related to system architecture, functionality, and operational procedures.
- Provide guidance and support to end-users, facilitating training programs to enhance system utilization and productivity.
- Identify potential risks related to GCO external systems, establish mitigation strategies, and ensure compliance with regulatory requirements.
- Engage and collaborate with third-party vendors, service providers, and stakeholders to manage contracts, performance and service level agreements (SLAs).
- Foster collaboration across functions to ensure seamless integration of clinical systems with corporate enterprise systems, thereby enhancing overall operational effectiveness.
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 & Enterprise policies 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-performing GCO Systems Management team focused on end-to-end system lifecycle management for all external GCO systems and platforms.
- Foster a culture of innovation, accountability and drive professional development.
Operational Excellence, Compliance & Governance: - Ensure all systems and platforms adhere to relevant pharmaceutical industry regulations and internal security policies.
- Liaise with vendors, Enterprise IT partners, audit, and compliance to coordinate system implementation and change activities
- Ensure the team is trained in and embeds CSV, compliance, and health authority requirements into operational activities.
Collaboration & Partnership: - Collaborate with R&D functions and teams on standards and best practices to attain 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: Education Required: - Bachelor's Degree in Computer Science or Information Technology
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.
