Role Summary
Sr. Director, Global Clinical Operations TA Head, Neuroscience. Lead the strategic and operational global execution of all clinical trials within the Neuroscience therapeutic area, overseeing a team of approximately 15-20 professionals and driving excellence in clinical trial delivery, cross-functional collaboration, and operational innovation from Ph1 through registration and post-marketing studies.
Responsibilities
- Define and execute the global clinical operations strategy and oversee 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 new processes, methodologies or operational ideas and re-challenge existing ones to improve services, effectiveness and efficiency
- Ensure programs have high-quality operational plans and activities aligned with the overall Clinical Operations and Development Teams strategy, including risk identification and escalation
- Lead due diligence activities by providing operational input as appropriate
- Partner with CQA to address quality issues, implement corrective actions including revision of processes and training, and 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 with external stakeholders (investigators, partners, consultants, service providers, CROs) to ensure vendor responsibilities (performance, quality & compliance, reporting) are met
- Accountable for the performance and results of a large to medium-sized department, including:
- Direct management, career development, and training of Global Clinical Project Managers (CPMs) and other GCO staff for timely execution of high-quality clinical studies within budget and SOPs; manage hiring and resource planning for the TA
- Foster a collaborative, innovative, problem-solving culture; develop high-performing clinical trial management teams; review and approve outsourcing specifications
- Oversee management of CROs, vendors, and consultants; collaborate with Procurement on performance and quality metrics
- Ensure communication of KPIs, achievements, risks, and mitigation plans to senior management
- Ensure studies meet regulatory requirements and are conducted to GCP/ICH standards globally
- Champion patient-centric approaches within clinical programs to enhance patient experience, diversity, and engagement
- Continuously acquire knowledge related to drug development, trials methodology, and clinical operations; integrate industry-leading concepts into GCO
Qualifications
- Required: BA degree (Graduate/MSc preferred) in applicable discipline and 15 years of related experience
- Strong global pharmaceutical management experience; at least 5 years in managing and developing a group of people
- Extensive knowledge of GCPs and ICH guidelines and clinical operations
- Proven experience in vendor and CRO management
- Proven experience in process improvement and design, project management, and budget management
- Proven experience in leading and executing clinical trials in Neuroscience
- Extensive knowledge of clinical trials methodology, drug development, and industry practices
- Preferred: Operational excellence, innovative and strategic thinking, scientific mindset
- Preferred: Experience leading and developing high-performing teams across geographies
- Preferred: Excellent interpersonal and communication skills with cross-functional collaboration
- Preferred: Ability to develop and implement business strategies across multiple disciplines and lead change efforts
Job-Specific Competencies
- Proven ability to provide clinical strategic operational expertise to the Neuroscience TA
- Ability to interface professionally with internal and external professionals
- Ability to manage multiple projects with aggressive timelines
- Ability to motivate, inspire, and grow direct reports and team members
- Demonstrates operational excellence, innovative thinking, scientific mindset, and strategic thinking
- Strong presentation and communication skills
- Extensive knowledge in clinical trials methodology
Education
- BA degree required; Graduate/MSc preferred
Additional Requirements
- Travel: Ability to travel with overnight stays up to 30% as needed
- Location: Hybrid schedule based out of Parsippany, NJ or West Chester, PA Teva offices