Senior Director Clinical Operations

59681 - Senior Director Global Clinical Operational Therapeutic Area Lead-Neuroscience

The opportunity:

The Sr. Director of Global Operational Therapeutic Area Lead, Neuroscience, is a core member of the GCO leadership team, responsible for the development of the operational strategy across the GCO organization. Within the assigned TA, the incumbent is accountable for the oversight and execution of global clinical programs across all phases, delivering high-quality studies to enable strategic decisions within the GCO organization.

How you’ll spend your day:

• Accountable for the development of the operational plans for clinical deliverables, effectively implementing design excellence in line with the Clinical Development Plan (CDP) and ensuring the principles of Good Clinical Practice (GCP).
• Lead global departmental core activity processes and tasks. Identify and initiate the development of new processes, methodologies or operational ideas and re-challenge existing ones to improve the services provided, effectiveness and efficiency.
• Ensure programs operational plans and activities with the overall Clinical Operations and Development Teams strategy while maintaining effective communication, including identification of risks and points of escalation.
• Lead due diligence activities by providing operational input as appropriate
• Partner with CQA to address quality issues, implementing corrective action including revision of processes and training within the indication or program. Ensure Inspection readiness of studies/programs within the TA (if applicable).
• Responsible to review and approve clinical program/study budgets and long-term forecasting for the respective TA
• Act as a 2nd Point of escalation for operational issues for Vendors and other Teva functions for all programs/studies within the TA.
• Accountable for the performance and results of a large to medium-sized discipline or department, including:
• Direct management, career development and training of Global Clinical Project Managers (CPMs) and other GCO staff responsible for the timely execution of high quality clinical studies within budget and according to SOPs. Manages the hiring and resource planning process for the TA.
• Foster a collaborative, innovative, problems-solving culture to develop high-performing managers
• Review and approve clinical outsourcing specifications
• Oversee management of the CROs, vendors and consultants, working closely with Procurement for performance and quality metrics
• Ensure the appropriate information is communicated to senior management including but not limited to KPIs, achievements, risks, and mitigation plans
• Responsible to approve program and study budgets and provide long-term forecasting for operational activities
• Responsible for communication to upper management:
• Senior Management Meetings
• Core Team and CDT Meetings
• Monthly R&D reports (GCO)
• Bi-weekly meetings with head Clinical Operations

Your experience and qualifications:

• BA degree (preferred Graduate/MSc degree) in applicable discipline
• 15 years of related experience
• Strong management and supervisory experience in a global company. Experience in managing and developing a group of people for a minimum of 5 years.
• Extensive knowledge of GCPs and ICH guidelines and clinical operations
• Strong experience in vendor and CRO management
• Experience in process improvement and design as well as project management and budget expertise
• Good Information Technologies orientation
• Good English language knowledge