Vertex Pharmaceuticals
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Cambridge,
MA
The Director, Clinical Operations will function as the Clinical Operations Program Lead and be responsible for the operational oversight for the Telaprevir program. Oversight includes operational strategy, timelines, metrics, budget and preparation for submissions. He/she will be a key member on the Clinical Development Team and other cross-functional forums. A driver for process improvement, this candidate would lead critical process initiatives and be part of the clinical operations leadership team that defines the clinical operation's role and trial governance at Vertex Pharmaceuticals.
Specifically, the Director role is to manage and drive the development and execution of high-quality, realistic, cross-functional, clinical trial plans, to apply trial management best practices in the development, initiation, planning, execution, control, and closing of trials, and to provide training and support resources to the Clinical Operations group. The Director will ensure clinical projects/programs are defined, tracked and communicated in a consistent and effective manner. The Director will direct project/program managers and will coordinate tracking of key project milestones. The Director will coach and hold accountable project managers by establishing a formal trial management methodology and ensuring it is followed, assigning resources to projects and supporting and assisting project managers in delivering their projects on time, on budget and critically, with high quality. A key focus of this position will to work with senior management on optimizing vendor management at all levels.
Key Responsibilities:
· Manages the Phase 3 Telaprevir portfolio of studies and ensures consistent operational strategy is applied. Manages the timelines, budget and resources for the project. Works with senior management in outlining opportunities, risks and mitigation strategies.
· Helps define and develop governance standards specifically for conducting clinical trials including: Project Planning/Tracking; Status Reporting; Issues Management/Escalation/Resolution; Risk Management; CRO/Vendor Management; Financial Management and Resource Management.
· Ensures continued utilization and maturation of best practice trial management standards and methodologies.
· Helps ensure the growth and success of project managers and their teams by providing mentoring and training in the project management, established clinical trial processes, policies and procedures, as well as tools and templates.
· Build and maintain cross-functional relationships
· Work with QA departments to perform audits of clinical trials and create clinical processes and methodologies related to achieving / supporting GCP and FDA compliance.
Minimum Requirements
* Global experience within all phases of drug development with advanced understanding of other functions; including but not limited to: Research, Non-Clinical, Supply Chain, Commercial, Regulatory and Medical Affairs
* Experience in strategic planning, business process improvement and achieving results.
* Experience in demonstrating leadership and influence and collaboration in a matrix environment
* Application of Project Management tools, methodologies, practices, risk analysis, decision analysis and contingency planning
* The ability to effectively communicate with Clinical Leadership and Clinical Project Managers
* Strong consultative, listening and analytical skills
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company’s strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex’s product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection.
Cambridge, MA
Cambridge, Massachusetts
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