Director Clinical Data Standards Jobs in Raleigh, NC

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.

We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in disease diagnosis, modeling, imaging, genomics, proteomics, and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards.

Strategic Leadership:

• Define and execute Clinical Data Science strategies for clinical studies and development plans across the portfolio.

• Serve as the primary spokesperson for Data Science at Health Authority meetings, leading preparation of responses and influencing regulatory perspectives.

Innovation & Execution:

• Drive adoption of cutting-edge AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine.

• Oversee multiple large-scale, critical data science initiatives, ensuring timely, high-quality deliverables aligned with industry best practices.

Risk Management & Problem Solving:

• Evaluate analytical options, proactively identify risks, and develop novel solutions to complex challenges.

Thought Leadership & External Engagement:

• Represent the organization at technical seminars and conferences; build networks with industry experts to advance best practices.

Team Leadership & Development:

• Manage and mentor a diverse team of data scientists and people managers across geographies.

• Foster career growth through open dialogue, performance management, and strategic development planning.

Operational Excellence:

• Ensure GxP compliance in data science programming for clinical trials.

• Manage budgets, vendor relationships, and third-party deliverables to maintain quality and efficiency.

Executive Communication:

• Deliver clear, compelling communication of complex data science concepts to internal and external stakeholders with executive presence.

Qualifications

• Ph.D. in Biostatistics or a Master's Degree in Biostatistics in combination with a Ph.D.in Bioinformatics or related computational sciences.
• Deep expertise in statistical methods and their application in clinical trials.
• Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics.
• Recognized thought leader in at least one data science discipline (e.g., AI/ML modeling, precision medicine).
• Proven experience presenting at external forums and influencing regulatory authorities.
• Strong people leadership experience in a Data Science setting.
• Prior research experience in neurology, particularly Alzheimer's disease biomarkers (plasma, CSF, imaging), strongly preferred.

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://careers.eisai.com/us/en/compensation-and-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.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Right To Work

E-Verify Participation