Covance is seeking a global leader with experience and management capabilities necessary to lead a large-scale clinical trial operation and organization. This leader will provide global leadership across multiple regions in a complex country management structure, while delivering extraordinary client performance for a pharmaceutical services-oriented CRO business.
Reporting to the Sr. VP, Global Trial Management and Operations, this leader will provide direction to senior Clinical Development and Commercialization Services (CDCS) regional leaders who are accountable for the overall welfare, retention and successful employee engagement of all CDCS regional employees. Therefore, the position focuses on global strategy and direction that enables consistency and quality in our global processes and delivery.
The position requires significant long-term experience in leading large-scale clinical trial operations and organizations, leading a regional/country management structure. Those considered will possess a consistent track record as an agent of change in challenging environments and in cultivating a confident and capable workforce.
Success will be assessed against 6 key areas: Operations, Quality, Commercial, Strategy, People and Financials.
- Demonstrate experience to lead and collaborate in a global matrix model, driving a committed pursuit to continually find ways to improve and streamline operations, anticipate problems, use financial tools to lead, and positively adopt a culture of rapid change.
- Lead the Global Clinical Trial Operations executive team in the pursuit of successful operational and financial performance to ensure clinical trial operations success.
- Provide leadership to the regional operations and functional heads who are accountable to ensure the delivery of all aspects of clinical trial study performance, management and quality (ie. study start-up, monitoring, etc). Oversee the review, evaluation and improvement of regional operational business performance and ensure effective alignment with global requirements and best-demonstrated-practices.
- Ensure the development and maintenance of regional networks with pharmaceutical/CRO industry, and liaise and negotiate where required with government agencies, industry representatives and key client groups.
- Responsible for ensuring all regional and functional clinical operations leaders drive: a) fully and completely implementing the divisional quality management plan; b) maintaining operations so that the function is always in a state of inspection readiness; c) that all TMFs are in a state of constant readiness; and d) that the organization is adhering to the CAPA management process.
- Responsible for ensuring that all regional and functional leaders / countries have an annual updated quality plan and lead their operations to the highest level of quality adherence and client expectations. Specifically, that all regional leaders are held accountable to proactively running their operations with a focus on continued quality improvement through active monthly review of trends, risk indicators, CQC and MQC reports, and use of the country quality dashboard reports.
- Drive quality accountability by ensuring Regional and Functional leaders are working with all managers and staff have ensure there are written relevant, manageable and measurable quality objectives in every employees’ annual performance management document.
- In executive partnership with the CDCS Business Development leadership team and the global and regional Account Executive team to dedicatedly support the winning of new business opportunities across all business lines.
- Represent CDCS to the most senior level global client representatives and support all global client business opportunities as required.
- Actively work with and support all Covance and LabCorp global business units at the executive level to increase their commercial success and support integrated new business opportunities.
- Implement and support Global Trial Management and Operations strategy and its initiatives.
- Influence, develop, and create future elements of the Epic Growth Transformation Strategy.
- Work with Regional and Functional Heads to ensure people management strategies are developed and implemented globally to provide CDCS employees with the tools, processes, and facilities to successfully and effectively perform their roles in an ever changing environment.
- Work with Regional and Functional Heads to review regional employee resourcing plans to ensure that all regional study work can be conducted on time, on budget, and meeting the implied customer quality and regulatory requirements.
- Be a seasoned, consistent and motivational communicator who can lead, attract talent, inspire confidence and loyalty, in a culturally diverse global team.
- Work with Regional and Functional Heads to oversee the delivery of the agreed regional: productivity goals, functional budget, cost-savings initiatives, and other key financial business success metrics.
- Work with Regional and Functional Heads to create value by maximizing asset utilization, engaging clients to win more regional new business, and significantly improving internal processes.
- Work with Regional Heads to develop new facility investment plans (CERs), leverage existing facilities to improve ROI, and implement proactive cost-reduction strategies.
- As the leader of the Global Clinical Trial Operations executive leadership team, responsible to deliver the planned annual financial targets of the Fast50 Transformational Strategy.