
Sr. Director, Global Clinical Operations TA Head, Neuroscience
- נתניה
- משרה קבועה
- משרה מלאה
- Define and execute the global clinical operations strategy and oversee the staff responsible for managing and executing all phases of clinical trials (excluding phase I healthy volunteer) within the Innovative Medicines Neuroscience TA
- 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 high quality 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
- Accountable for reviewing and approving clinical program/study budgets and long-term forecasting for the Neuroscience TA
- Together with Alliance management, establish and foster relationships and professional contact with external stakeholders including investigators, partners, consultants, service providers, and CROs, ensuring that vendor responsibilities such as performance, quality & compliance, and reporting are met
- 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.
- Fosters a collaborative, innovative, problem-solving culture and mindset and develops high-performing clinical trial management teams 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
- Ensures that all studies meet regulatory requirements and are conducted to GCP/ICH standards globally
- Champion patient-centric approaches within clinical programs, ensuring operational strategies align with enhancing patient experience, diversity, and engagement.
- Continuously acquires knowledge related to drug development programs, clinical trials methodology and clinical operations and integrates industry leading concepts into GCO
- BA degree (preferred Graduate/MSc degree) in applicable discipline and 15 years of related experience
- Strong management and supervisory experience in a global pharmaceutical company. Experience in managing and developing a group of people for at least 5 years.
- Extensive knowledge of GCPs and ICH guidelines and clinical operations
- Proven experience in vendor and CRO management
- Proven experience in process improvement and design, as well as project management and budget expertise
- Proven experience in leading and executing clinical trials in Neuroscience
- Extensive knowledge in clinical trials methodology, drug development, and overall industry knowledge
- Ability to demonstrate operational excellence, innovative & strategic thinking, and scientific mindset
- Ability to lead and develop high-performing teams across geographies
- Excellent interpersonal and communication skills with a track record of effective cross-functional collaboration and stakeholder management
- Ability to develop and implement business strategies across multiple disciplines and proven success in leading change efforts
- Proven ability to provide clinical strategic operational expertise to the Neuroscience TA
- Ability to interface professionally with a wide spectrum of internal and external professionals
- Ability to work on multiple projects with aggressive timelines
- Ability to motivate, inspire and grow direct reports and team members
- Ability to demonstrate operational excellence, innovative thinking, scientific mindset and strategic thinking
- Strong presentation and communication skills
- Extensive knowledge in clinical trials methodology