Executive Director, Oncology Clinical Development

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.

Responsibilities:

• Provide leadership and successfully manage clinical research programs, and key business objectives within the department.
• Implement clinical research strategy across teams, to accomplish critical milestones across programs in compliance with Eisai's SOP's and regulatory guidelines.
• Direct program level oversight of Clinical development plans (CDP) and drug development Plans (DDP) for marketed products as well developmental compounds prior to first NDA/MAA.
• Establish and maintain relationships at leadership levels in the organization to influence adoption of best practices.
• Exercise judgment and discretion on a consistent basis within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Strategically engage and influence critical internal and external stakeholders (e.g. affiliates, regulatory bodies) to drive long-term objectives across projects/programs.
• Ensure targets are clearly defined within teams, important information cascaded well and accountability driven in the organization.
• Oversee resource planning, budgeting, financial reporting, forecasting and process development within own department in line with strategic priorities.
• Look at the pipeline of talent within the clinical development team as an organizational pool, investing in future skills, spending time giving feedback, coaching, and challenging high potential members with different assignments.

Qualifications:

• Bachelor's degree (Master's preferred) and 15+ years of relevant experience.
  Experience in Life Sciences industry preferred.
• PhD/PharmD in relevant scientific discipline with significant industry experience in relevant technical field and/or clinical research experience in industry.
• (OR) MD, Medically trained with significant clinical research experience in academia or industry
• (OR) a combination of equivalent education & experience.
• Significant pharmaceutical industry clinical development experience (in oncology/neurology) with knowledge of translational, Phase I, II, and III studies.
• Proven success driving clinical research strategies, designing and providing oversight of clinical programs.
• Demonstrated experience in stakeholder management, vendor management, budget planning & resource management.
• Demonstrated track record as Study Director (or equivalent role) with Global Clinical Lead or Clinical Program Director accountability.
• Proven experience in running clinical studies with an understanding of Clinical Operations and Data Management preferred.
• Significant experience working with FDA or EMEA regulatory agencies handling responses to inquiries and requests for study related information.
• Strong knowledge base of the drug development process.
• Deep knowledge of the specific therapeutic area.
• Proven track record of clinical/project leadership in a matrix environment leading and directing clinical research teams in a leadership capacity.
• Proven performance in earlier role including strategic oversight, people management, and strategic stakeholder management across levels internally and externally.

Eisai Salary Transparency Language:

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://us.eisai.com/careers-at-eisai/benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

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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