Senior Manager Clinical Study Lead (Cell Therapy)

Role Summary

The Senior Clinical Study Lead (CSL) is accountable for the global execution of assigned large and/or complex clinical trials from study design through execution to study close out, ensuring study timelines and budget alignment with Regeneron SOPs and ICH/GCP. This role may involve internal studies or work with CROs, with varying levels of direct leadership versus oversight. Drives ongoing process improvements.

Responsibilities

• Lead the cross-functional study team responsible for clinical study delivery and serve as the primary point of contact for leadership and oversight for the assigned study
• Provide operational input into protocol development
• Oversee and input into study-specific documentation (CRFs, data management plan, monitoring plan, monitoring oversight plan, training plan, data review plan, statistical analysis plan, etc.)
• Oversee setup and maintenance of study systems (CTMS, TMF, etc.)
• Ensure compliance with clinical trial registry requirements
• Identify outsourcing needs and lead engagement, contracting and management of vendors
• Provide input into budget and timeline development and management
• Lead risk assessment and mitigation at the study level
• Lead feasibility assessment to select relevant regions and countries
• Oversee site evaluation and selection; lead investigator meeting preparation and execution
• Monitor site activation and monitoring visits, addressing deviations from plan
• Lead development and implementation of patient recruitment and retention strategies and address deviations
• Monitor data entry and query resolution, addressing deviations from metrics
• Ensure accurate budget management and scope changes for internal and external studies
• Oversee study drug and clinical supplies forecasting, drug accountability and reconciliation
• Escalate issues related to study conduct, quality, timelines or budget and implement actions
• Oversee study execution against timelines, deliverables and budget
• Monitor data quality, including metrics, protocol deviations, eligibility violations, dosing deviations, and suspected non-compliance by sites
• Ensure CROs and third-party vendors are aligned and delivering per scope of work
• Ensure audit and inspection readiness; support internal audits and external inspections and contribute to CAPAs
• Manage study close-out activities (database lock, vendor contract reconciliation, budget, TMF, drug accountability)
• Contribute to clinical study report writing and review; facilitate study-level lessons learned
• Assign tasks to Clinical Study Management staff and support deliverables
• Recommend and participate in cross-functional/process improvement initiatives
• Identify innovative approaches to clinical study execution and continuous improvement of CTM SOPs
• May perform unmasked tasks as assigned (e.g., handling unmasked product, unmasked TMF, IVRS issues, monitoring)
• Directly supervise CTM staff; manage performance, recruitment, development, coaching, training and compliance
• Travel up to 25%

Qualifications

• Required: Bachelor‚Äôs degree and minimum 8 years of relevant clinical trial experience
• Preferred: Background in cell therapy clinical trials
• Strong interpersonal and leadership skills; data-driven planning, execution and problem-solving
• Advanced communication and negotiation abilities; ability to influence across stakeholders
• Strong budget management experience and awareness of industry trends
• Ability to build and develop productive study teams and collaborations
• Advanced negotiation and vendor management skills
• Technical proficiency in trial management systems and MS Office (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC)
• Extensive experience in global clinical trial operations; knowledge of protocols and key study documents
• Knowledge of ICH/GCP and regulatory guidelines
• Advanced project management and cross-functional leadership
• Line management experience

Education

• Bachelor‚Äôs degree required

Additional Requirements

• Onsite work requirement at a Regeneron location (Armonk, NY; Warren, NJ; Cambridge, MA; Dublin, Ireland; Uxbridge, London) with possible travel up to 25%