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.

The Director, Clinical Development is a newly created role for a dynamic individual with clinical leadership experience in the pharmaceutical industry. The position is intended to provide the organization with a qualified individual to design and oversee the conduct of clinical studies for Phase 2 and 3 development and post-marketing of compounds targeting neurodegeneration. Additionally, this individual will contribute to the organization by analyzing and communicating results for these studies and by providing input into clinical development strategies as well as by performing medical monitoring for these and, possibly, other studies within the Neurology Group.

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.

Skills:Clinical Development Knowledge/Skills, Communication & Cross-functional Influence, Critical Thinking & Business Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Scientific Research & Econ Modeling

Eisai Salary Transparency Language:

The base salary range for the Director, Clinical Development, Neurology is from :294,900-387,000

Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.

Final pay determinations will d