Executive Director, Clinical Development Operations Systems
- Provides functional leadership, oversight, and strategic direction for the successful management of Development Operations Systems; a group, that functions as a dedicated, centralized framework to provide strategic and technical consultation and internal customer service for Development Operations and its stakeholders' systems and associated processes. Core stakeholders for systems are Clinical Operations, Clinical Data Science, and Regulatory Affairs.
- Lead and develop a team of direct reports (Senior/Directors) and a broader staff of approximately 100 (including employees and contractors)
- Accomplishments achieved through collaborations with functional subject matter experts and governance in the development, integration, and life cycle management of systems and documentation to improve standards, processes, training, quality, analytics, and business intelligence for projects aligned with Development Operations goals
- Responsible for oversight and strategic direction and implementation across a number of projects to ensure Development Operations systems and processes meet project milestones and budgets through close partnership with parties involved both inside and outside of the company
- Initiates continuous efforts of improvement in reviewing, identifying, and developing best practices and enforcing standardization
- Directs collaborative process document development and provides integrated systems solutions to in a consultative manner in respect to long range goals for Development Operations and Gilead
- Travels nationally and internationally as required
- Acts as company spokesperson at professional events and presents company clinical initiatives and findings at such events
- Bachelors Degree in a scientific discipline with16+ years OR Masters Degree in scientific discipline with 14+ years of relevant clinical systems/process/operations experience in the pharmaceutical industry. An advanced degree is desirable.
- Proven ability to lead multifunctional teams; manage and develop employees, and mentor junior employees
- Extensive operational experience and knowledge of advanced concepts
- Must be able to solve unique, complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines
- Must be able to successfully develop, implement, manage and complete complex business problems and direct vendor relationships
- Proven ability to think critically and creatively and be able to work independently and collaboratively to determine appropriate resources for resolution of complex problems that address long-range goals and objectives
- Demonstrated excellence in complex project management and effectively managing multiple projects/priorities
- Experience managing cross-functional teams or work groups as well as direct reports
- Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials is required
- Experience with giving presentations before executive staff and external peers
- Extensive experience in developing RFPs, selection of vendors, and management of external resources is required
- Previous experience defining budgets and timelines for international clinical trials and managing to them
- Proven ability to effectively communicate technical and advanced organizational concepts to internal and external customers
- Ability to initiate, and lead departmental or interdepartmental strategic initiatives
- Ability to advance concepts, develops new techniques, and be a subject matter expert in field within the company
- Solutions driven
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