Senior Director, Clinical Data Management

SUMMARY/JOB PURPOSE (Basic purpose of the job):

The Senior Director, Clinical Data Management (CDM) is a highly experienced and influential leader with expert knowledge of Clinical Data Management concepts and processes. This position is accountable for the strategic and operational leadership of CDM activities across all clinical studies Phase I to IV, with organizational scope and demand of internal FTEs, FSP resources, as well as fully outsourced studies across geographic regions.

The role requires a well-established leader, with a recognized track record of substantial organizational development and leadership, assuring efficient production and quality of all CDM deliverables. This role has independent decision-making authority for decisions that could have significant/long-term impact on the direction and effectiveness of the CDM organization.

The Senior Director, CDM is accountable for the management, development, recruitment and training of employees within the departmental scope, including Director level roles, to meet current and future business needs.

This position is expected to be capable of representing CDM and Data & Statistical Sciences in a leadership capacity. The role requires strong partnership and close collaboration with senior functional and matrix leaders across the R&D organization to ensure the successful, efficient, high-quality, and compliant delivery for the portfolio area.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Key member of the CDM Senior Leadership Team with accountability for assigned clinical programs with a combination of FTEs, Functional Sourcing Provider (FSP) or fully outsourced resources with a combination of on-shore and off-shore resources.
• Responsible for functional Clinical Data Management leadership with high material impact for company in a strong competitive landscape. Needs to navigate challenging and complex organizational structure of a growing company.
• Strategic leadership accountabilities include driving the development of capabilities and shaping organizational structures across a growing and complex functional portfolio.
• Provides exceptional leadership to employees within responsible areas. Leads coaching and development of employees, including Director level individuals across the function.
• Represents department in cross-functional discussions and step-in for Head of CDM as needed. Lead discussions with senior R&D colleagues to strengthen coordination between cross-functional and cross-sector departments. This position has direct interface with senior stakeholders and influencers across R&D including TA, Functional Leaders, and partnering functions including Information Technology, Strategic Sourcing & Procurement and others.
• Aligns with Business, Functional, and TA Heads/teams on key portfolio objectives and priorities to develop and influence the strategy and direction of CDM. Interacts with R&D colleagues, therapeutic or functional area leaders to execute on the organizational priorities, with a focus on quality CDM deliverables.
• Excellent organizational ability to manage CDM workload (incl across TAs) and ensure appropriate resource allocation is in place for optimal portfolio support. High level of vendor engagement/utilization with potential to impact and drive vendor capacity due to span of portfolio demand.
• Leader in continuous development and adjustment of innovative operating models. Able to lead, inspire and influence team/organization through rapidly changing business challenges.
• Provides a leadership role in department process development and optimization of related clinical research activities. Sponsors/leads initiatives with impact to drive change within and across functions and sectors.
• Drives cross-functional senior leadership engagement to develop and deliver solutions for new service capabilities.
• Works with Head of CDM to ensure the department strategy and processes are clear towards all stakeholders with optimal communication and engagement. Align processes and priorities to maximize organizational effectiveness; designs and implements innovative approaches to enhance productivity and effectiveness.
• Externally leads and sought-after for…