Job Description

Key Responsibilities:

Provides functional leadership, oversight, and strategic direction for Development Operations Systems, a centralized department that provides strategic and technical direction, consultation, and support for systems utilized by Development functions, including Clinical Operations, Clinical Data Science, Global Patient Safety and Regulatory Affairs
Leads and develops a team of direct reports (Directors/Associate Directors) and a broader staff of approximately 40 employees and contractors across multiple regions
Responsible for oversight, strategic direction and implementation of systems-related projects under DOS’ purview, ensuring project milestones and budgets and system requirements are met
Collaborates with functional subject matter experts in the development, integration, and life cycle management of systems to achieve one or more of the following:  increased efficiency through automation, improved workflows, standardization, or system simplification; higher system adoption; better quality outputs and metrics, improved analytics capabilities
Contributes to the development and update of the Development organization’s digital strategy and technology roadmaps in close collaboration with business and IT partners
Initiates continuous improvement efforts, identifies and develops best practices, and enforces standardization when appropriate throughout the system implementation lifecycle
Provides system selection, implementation, and integration architecture decision making and consultation
Travels nationally and internationally as required

Minimum Qualifications:

Bachelors degree with 14 years or Masters degree with 12 years of relevant systems/process/operations experience in the pharmaceutical industry
Proven ability to lead multifunctional regionally distributed teams, and to manage and develop employees
Demonstrated excellence in forging and maintaining collaborative, positive and long-lasting partnerships with system stakeholders: functional leaders, end-system user communities, IT, external partners
Demonstrated excellence in initiating, leading, or providing strategic direction for multiple concurrent departmental or interdepartmental projects and initiatives
Extensive experience in developing and implementing resource plans, developing RFPs, selecting vendors, and managing external resources
Proven ability to think critically and creatively to solve complex problems and address long-range goals and objectives
Demonstrated understanding of the pharmaceutical development process, including regulatory requirements and their impact on the conduct of clinical trials
Applied understanding of computer system validation methodology, development, and execution
Proven ability to effectively communicate and present technical and advanced organizational concepts to internal and external customers
Experience in effectively prioritizing departmental projects against a multi-million-dollar annual budget
Extensive experience with eCTD, CTMS, eTMF and RIM systems

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