Business Platform Lead Standards, Analysis & Reporting (Director, Global Clinical Solutions)

Location: Warsaw, Poland
Hybrid model of work: 3 days in office, 2 remot

Global Clinical Solutions (GCS) drives the delivery of Technology and associated processes for the BioPharmaceuticals R&D organisation, owning and providing industry leading technology and services on behalf of Development Operations and its internal and external Partnerships.

The Business Platform Lead Standards, Analysis & Reporting is a member of Global Clinical Solutions Technology group, and is responsible for the strategic leadership, lifecycle management and continuous improvement of two specific technology platforms. The Business Platform Lead works with the Head of GCS Technology, System and Functional Process Owners, UAT Test Leads and cross functional business leaders to ensure customer needs are prioritized and met. The BPL drives the implementation of innovative technology and innovation on the platform, from concept to roll-out, ensuring appropriate organisational change management is implemented.

The BPL works collaboratively with Redefining Clinical Data Flow Leads, Clinical Data Insights, Biometrics as well as other Transformation Leaders influencing technology and strategy, shaping, and delivering agreed vision and roadmap. Making sure the technology platform is in alignment with data integrity, quality and compliance, customer expectations, and with a high degree of automation.

The BPL balances operational excellence, technical innovation together with governance, quality, and compliance. The role coordinates implementation of changes and improvements across all components of the technology platform by leading and managing the GCS-Tech system/product owners and business system support team and by close collaboration with IT representatives, especially IT Platform Leads.

The role includes a mix of direct, matrixed, and 3rd party contract resources to coach and line manage.

Individuals with this role will influence on a global level, typically leading global teams based in multiple countries.

The Business Platform Lead may act as a System Owner of R&D critical systems or as Product Manager for complex systems managed under the Agile framework.

Typical Accountabilities

1) Technology Platform Strategy, Performance and Compliance Oversight
As the allocated owner for a specific Clinical Operations Technology Platform BPL is:

• Responsible for leading or overseeing delivery of systems solution implementation projects, including, and aligned with the AstraZeneca Technology strategy and 2030 Bold Ambition.
• Manage and build tight collaboration with Technology Vendors and their organisations.
• Ensure systems within defined technology platform meet quality and compliance regulations, global and local procedural documents and local implementation of Development Operations objectives, policies, processes, and procedures.
• Ensure systems within defined technology platform continue to meet business requirements, have assigned clear business benefits and goals, and deliver the expected business value across the whole value chain it enables.
• Support the ongoing business utilization of systems within the platform, troubleshooting problems, finding solutions, and support audit and inspection activities as a technical reference expert.
• Function as the point of escalation for GCS personnel as well as for external stakeholders for any risks and issues identified for the relevant systems.
• Communicate, build awareness, create, and facilitate information flows about allocated technology platform and associated deliveries on internal and external social platforms and events e.g., conferences.
• Responsible for the leadership of business support teams within the allocated area.
• Engage and influence internal and external key stakeholders to drive the strategy, development, and continuous improvement within the allocated technology platform.
• Ensure customer requirements are understood, critically evaluated, prioritised, and addressed within the allocated area. Work with GCS Leadership and Development Operations Leadership to prioritise the needs and resources required to deliver requirements, provide feedback, and clear rationale for any areas that will not be addressed.
• Responsible for monitoring performance of the allocated systems. Collaborate with System Owners to define, track and monitor key performance indicators and use these data to inform selection of process improvements and input to cross-functional improvements, working in collaboration with R&D IT and Clinical Data Insights Data Automation.
• Actively seek and promote creative and innovative ideas to drive performance and bring innovative solutions to customers.
  

2) Global Line Management:

• Provide global management and leadership to fulfil global management accountabilities and local employment law requirements (Global – in Development Operations locations)
• Build a strong, resilient, and flexible team that can take on challenges and changes in internal and external environments.
• Attract, develop, and retain top talents and actively work to promote team building and morale within the department.
• Provide direction, real time situation mentoring, career development guidance and coaching as appropriate.
• Provide performance management, performance assessment and reward and recognition proposals for direct reports.
• Develop and nurture future AZ leaders by leading and driving the capability development of the GCS Technology function.

3) Functional Partnering

• Manage a diverse set of senior stakeholders and interest groups in a changing organisational landscape.
• Member of Operational Steering Committees and Governance Teams relating to the assigned technology platforms.
• Ensure customer requirements in relation to assigned technology platform are understood, critically evaluated, prioritised, and addressed. Work with GCS Leadership and Clinical Operations Leadership to prioritize the needs and resources required to deliver solutions and provide clear rationale for any areas that not addressed.

Essential

• Bachelor of Science (BSc) in an appropriate discipline or equivalent experience
• A deep understanding of the business processes, technology, clinical trial information, regulations and guidelines impacting the drug development process (preferably at least 7 years’ experience from within the pharmaceutical industry or clinical research organization)
• A track record in identifying, leading, and delivering core and innovative clinical trial technology and systems change in large organization.
• Extensive knowledge of current and emerging technology in the clinical trial setting
• Significant experience in system ownership in a regulated environment and maintaining system compliance (preferably at least 3 years of experience)
• Project Management and delivery of technical or technology related projects
• Experience in vendor and supplier management, including development and assessment of requirements for proposal, contract development and negotiation, and managing budgets.
• Demonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills.

Desirable

• Expert reputation within the business and industry
• Experience of using Agile approaches at scale, across projects and products
• Certified in a Project Management Framework e.g., PMP
• Proven team or line leadership experience (preferably at least 3 years of experience)
• Experience in the development and management of Business Process to deliver business performance
• Experience in Validation of computerised systems in a regulated environment, preferably the pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts, etc. and knowledge of regulatory (GxP, SOX, etc.) requirements for computerised systems and infrastructure.
• Experience in a technical or IT role, or the ability to demonstrate understanding of complex technical themes and activities