Vice President, Clinical Operations

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

Head of Clinical Operations

Position Overview:The Vice President/Head of Clinical Operations is a senior leadership role responsible for overseeing all aspects of clinical trial execution within a pharmaceutical or biotechnology company. This role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers and other clinical operations staff while strategically planning and managing multiple clinical development programs across different phases.

The VP of Clinical Operations is responsible for the management, oversight, and direction of the clinical operations function in the execution of all aspects of end-to-end clinical trials with the utmost compliance and quality consistent with Good Clinical Practice (GCP). This individual must effectively balance strategic vision with hands-on operational management strategies to expedite clinical operations activities. These activities directly impact the timeliness, quality, and successful execution of clinical studies in accordance with the overarching project plans established by the various International Project Team Leaders (IPTLs). This role requires a deep understanding of the entire clinical trial process, from initial planning and protocol development through to study close-out and reporting, ensuring seamless coordination and integration of all clinical operations components.

Key Responsibilities:

• Manage and oversee the clinical operations function, ensuring compliance with GCP and regulatory standards.
• Develop and implement strategic vision and hands-on operational management strategies to expedite clinical operations activities.
• Ensure the timely, quality, and successful execution of clinical studies in alignment with project plans established by IPTLs.
• Oversee the TMF department, ensuring the management, oversight, and direction of TMF across all business functions.
• Provide training and oversight to employees and CROs on timeliness, completeness, and quality metrics.
• Manage the Safety Alert Reporting Departments, ensuring high-quality and timely global distribution of safety alerts and reports.
• Collaborate with IPTLs and other stakeholders to ensure alignment and successful execution of clinical trials.
• Monitor study progress, identifying and mitigating potential risks and issues.
• Establish and maintain relationships with senior leadership and other stakeholders to drive results.
• Engage and influence external stakeholders, including CROs, alliance partners, and key vendors, to ensure successful execution of clinical studies.
• Build and mentor a team of Clinical Operations staff to oversee all aspects of clinical trial development.
• Lead clinical study inspections from preparation through resolution with various Health Authorities.
• Communicate complex research ideas and insights to diverse internal and external audiences with executive presence.
• Invest in the development of future skills within the clinical operations team, providing feedback, coaching, and challenging high-potential members with different assignments.
• Provide leadership and expertise for global development initiatives aimed at improving quality, efficiency, innovation, and timeliness of work processes.

Qualifications:

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

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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