Director, Late Phase Operations

Director, Late Phase Operations Department/Division: Project/Program Management Job Type: Full Time Company: Vertex Pharmaceuticals, Inc. Location: Cambridge, MA 02139 Job Reference Id: 169BR   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. He/She will be responsible for overall leadership of Vertex's Telaprevir program, responsible for the operational oversight for the current Telaprevir Phase 3 and lifecycle programs. Oversight includes operational strategy, timelines, metrics, budget and preparation for submissions. A managerial position, this candidate would be a key member on the clinical development subteam 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 moving forward. Specifically, the 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 Program Management group. The telaprevir clinical operations program lead will ensure clinical projects/programs are defined, tracked and communicated in a consistent and effective manner. The role 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.The key responsibilities are as follows: Manages the Phase 3 and lifecycle Teleprevir program 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. Provides a program to ensure 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. Provides consultative services to Clinical Program Management in all areas of trial management. Builds and maintains cross-functional relationships as well as provide reports to senior management. Works with QA departments to perform audits of clinical trials and create clinical processes and methodologies related to achieving / supporting GCP and FDA compliance.QualificationsThe candidate should possess demonstrated 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, influencing senior management, partnering with various departments, client and support groups, business process improvement, and achieving results. Experience in demonstrating leadership, influence and collaboration in a matrix-managed environment. Application of Project Management tools, methodologies, practices, risk analysis, decision analysis and contingency planning. The ability to effectively communicate with clinical development leadership and clinical project managers Strong consultative, listening and analytical skills strong coaching and communication skills. Master's Degree within a clinical or scientific discipline preferred. Vertex Pharmaceuticals Inc., is an EQUAL OPPORTUNITY EMPLOYER. APPLY NOW