Director, Clinical Research at Eisai in Woodcliff Lake, New Jersey

Job Description:

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.

Job Summary

The Director, Clinical Research 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 of compounds targeting dementia and, in particular, Alzheimer's Disease. 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 potentially performing medical monitoring for these and, possibly, other studies within the Neuroscience Business Group.

Essential Functions

• Assisting the project team clinical lead in planning, implementation, managing and reporting of CDPs and programs.


• Developing Clinical Protocols to meet the objectives of the CDP.


• Serving as a Study Director for selected trials and delivering final protocol, implementation strategy and clinical data review plans.


• Depending on credentials, the hired candidate may serve as a medical monitor and provide input into clinical issues, adverse events, laboratory data, patient inclusion/exclusion criteria.


• Identifying, monitoring and resolving clinical program/trial issues, and reporting progress to management.


• Serving as the SME to provide input to project teams across functions, presenting at Advisory Board meetings, and liaising with KOLs regarding protocol study strategy and issues.


• Interpreting study data and developing integrated summaries of safety and efficacy.


• Participating in the selection of new compounds for clinical development and IND filings in Neuroscience (especially in the area of dementia therapeutics) through technical evaluation of licensing and/or partnering opportunities. This includes developing and implementing paradigms for novel data analyses.

Requirements

• MD candidates with 3+ years of industry clinical research experience in Neuroscience.


• PhD candidates with 8+ years in clinical research in the pharmaceutical industry, preferably with experience in Neuroscience and especially Dementia (e.g., Alzheimer's disease).


• A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation.


• Working knowledge of currently available clinical technologies and assessment tools, and drug mechanisms of action.


• Knowledge of GCP and local regulatory requirements.


• Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industrial experience.


• Knowledge of medical, scientific and clinical research techniques in the neurology/psychiatry therapeutic area.


• Knowledge of the role of biomarkers and neuroimaging in evaluating pharmacodynamic effects and proof-of-pharmacology.

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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