System Owner- Clinical Control Tower (Associate Director, Global Clinical Solutions)

Location: Durham, NC
Hybrid model of work (3 days from the office, 2 days from home)

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 System Owner (SO) is a member of Global Clinical Solutions, Technology department and is end-to-end accountable for the leadership, lifecycle management and continuous improvement of Clinical systems as assigned. The System Owner can cover one or more systems in the Clinical space.

The System Owner works closely with vendor(s) if applicable, R&D IT (Information Technology), Functional Process Owners, Business Process Management Office (BPMO), internal and external customers and stakeholders to ensure customer needs are met and to enable optimal end-to-end delivery of clinical studies. Responsible for the identification, definition and delivery of improvements in end-to-end clinical study delivery, utilising tools and techniques to achieve continuous improvement and value creation (i.e. Lean Six Sigma).

The SO ensures that the System meets ICH/GxP requirements and aligns with industry direction, standards, and best practices.

The System Owner represents the business interests in strategy discussions and provides strategic advice to the Governance team in securing long-term business success of their assigned system(s). Reviews and approves (if acceptable) identified system risks and mitigations. Controls and prioritizes all business requests, such as those for feature enhancements, ensuring prioritization takes place so resources (staff, vendor budget) are spent on value-add activities. Accountable for communication to key stakeholders and the business regarding the system (major incidents, new releases,

etc.)

All System Owners will lead and manage improvement projects as needed, and will contribute to functional, regional and or

global initiatives.

Typical Accountabilities

• Governance Leadership

Chair or co-chair internal steering committees and operational governance forums.Ensure alignment with IT & DevOps and agile methodologies for continuous improvement. 

• Operational Oversight

Monitor KPIs, manage risk reviews, and oversee product roadmaps.Coordinate with vendors and internal teams on incidents, escalations, and change control boards (CAB/CCB).

• Lifecycle Management

Drive transition from project phase to Business-As-Usual (BAU), ensuring readiness for ongoing studies.Maintain compliance with governance frameworks and license-to-operate requirements. 

• Stakeholder Engagement

Act as the primary point of contact for business partners, IT leads, and vendor representatives.Facilitate PI planning and cross-team dependency management.

Essential

• Bachelor of Science (BSc) in suitable discipline or equivalent experience

• Extensive experience in Drug Development within a pharmaceutical or clinical background

• High-level of business process, technology and Clinical Study information knowledge.

• In-depth knowledge of Agile process and principles

• requirements for computerised systems and infrastructure

• Demonstrated project management skills and proven skills to deliver to time, cost and quality

• Ability to work collaboratively, motivate and empower others to carry out individual, team and organizational objectives.

• Experience in working successfully and collaboratively with external partners (vendors) delivering mutual benefit

• 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

• Comprehensive knowledge of ICH/GCP

• Recognised AGILE certification (e.g. SAFe)

• Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment

• Project Management certification

• Service Management experience. Incident, Problem, Change and Release Management (ITIL) Project Management certification

• Experience in the development and management of Business Process to deliver business performance

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.