Director, Clinical Development, Neurology

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 scientific support for clinical development planning, study design/execution, and data monitoring to ensure successful implementation of high-quality clinical development programs.
• Lead and manage moderately complex clinical research areas and may occasionally be responsible for program oversight.
• Serve as a medical monitor and provide input into clinical issues, adverse events, laboratory data and patient inclusion/exclusion criteria.
• Adapt and present complex scientific findings to diverse audiences to aid meaningful interpretation and action.
• Scout emerging clinical research & technology landscape related to own area to identify relevant processes/technologies; present case for adoption within Eisai.
• Serve as a subject matter expert to provide input to project teams across functions, presenting at advisory board meetings, and liaising with KOLs regarding protocol study strategy and issues.
• Guide cross-functional coordination/collaboration with internal and external research groups for clinical research studies.
• Actively manage complex operational issues pertaining to clinical studies in conjunction with project and study teams.
• Maintain current knowledge and awareness of internal and external developments (e.g. scientific, clinical, competitive, and regulatory) by actively participating in major scientific conferences, competitive intelligence activities and engaging in periodic literature review.
• Lead processes for team management in terms of goal setting, performance, development, and engagement.

Qualifications:

• MD/PhD; MD candidates with 3+ years of industry clinical research experience in Neuroscience, preferably Neurodegeneration, Dementia and/or Alzheimer's Disease.
• A thorough understanding of clinical research methodology including study design, protocol writing, CRF preparation, and Clinical Study Report preparation.
• Experience directing late stage development and post-marketing studies; Regulatory filing experience a plus.
• Significant experience managing clinical research budgets, project management, contract/vendor management and regulatory filings.
• Comprehensive knowledge of clinical research methodology including study design, protocol writing, and CRF preparation.
• Experience with latest clinical technologies and assessment tools, and drug mechanisms of action.
• Strong experience using scientific and clinical research techniques in the neurology/psychiatry therapeutic area.
• Some experience managing people directly or through matrixed relationships preferred.
• Strong working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industrial experience.
• Firm knowledge of ICH-GCP and local regulatory requirements.
• Proven performance in earlier role.

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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