Director Clinical Operations: Careers

Our client is a global biopharmaceutical company.  They have asked us to assist them in their search for a Director Clinical Operations. 

He/she will function as the Clinical Operations Program Lead for an infectious disease drug program. He/she will be responsible for the operational oversight for the current infectious disease drug Phase 3 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 the company.

Specifically, the Director’s 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 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.   The Director Clinical Operations:

• Manages the Phase 3 infectious disease drug 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.
• 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.
• Provide consultative services to Clinical Program Management in all areas of trial management.
• Build and maintain cross-functional relationships as well as provide reports to senior management.
• Work with QA departments to perform audits of clinical trials and create clinical processes and methodologies related to achieving / supporting GCP and FDA compliance.

We seek candidates with the following qualifications: