Job Description:

We are seeking a highly motivated and experienced Vice President/Head of Global Clinical Operations to join our team at Eisai, Inc.

This role is responsible for overseeing all aspects of clinical trial execution within a pharmaceutical or biotechnology company, ensuring studies are conducted efficiently, within budget, and in compliance with regulatory standards.

Key Responsibilities:

• Manage and Oversee Clinical Operations: Ensure compliance with Good Clinical Practice (GCP) and regulatory standards.
• Develop Strategic Vision: Implement hands-on operational management strategies to expedite clinical operations activities.
• Ensure Timely Execution: Lead the timely, quality, and successful execution of clinical studies in alignment with project plans established by International Project Team Leaders (IPTLs).
• Oversee TMF Department: Manage, oversee, and direct TMF across all business functions.
• Provide Training and Oversight: Train and oversee employees and CROs on timeliness, completeness, and quality metrics.
• Manage Safety Alert Reporting Departments: Ensure high-quality and timely global distribution of safety alerts and reports.
• Collaborate with Stakeholders: Collaborate with IPTLs and other stakeholders to ensure alignment and successful execution of clinical trials.
• Maintain Relationships: Establish and maintain relationships with senior leadership and other stakeholders to drive results.
• Engage External Stakeholders: Engage and influence external stakeholders, including CROs, alliance partners, and key vendors, to ensure successful execution of clinical studies.
• Build and Mentor a Team: Build and mentor a team of Clinical Operations staff to oversee all aspects of clinical trial development.
• Lead Clinical Study Inspections: Lead clinical study inspections from preparation through resolution with various Health Authorities.
• Communicate Complex Ideas: Communicate complex research ideas and insights to diverse internal and external audiences with executive presence.

Qualifications:

• Bachelor's Degree: Bachelor's degree in biological science, nursing, pharmacy, or a related field. Advanced degree preferred.
• Regulatory Experience: Proven effectiveness in engaging with and addressing regulatory agencies.
• Clinical Operational Strategy: Experience in leading clinical operational strategy development, stakeholder management, vendor relationship management, and budget planning.
• Leadership Experience: Extensive experience in directing large/global clinical trials teams across different stages of study in a leadership capacity.
• Clinical Operations Methods: In-depth knowledge of clinical operations methods and processes in an industry setting.
• Strategic Implementation: Proven track record of successful implementation of innovative strategies.
• Related Functions: Experience in managing and directing related functions such as data management, CRO vendor management, procurement, and contracting.
• Communication Skills: Excellent communication and interpersonal skills.

Eisai, Inc. is an equal opportunity employer and participates in E-Verify.