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Job Details

Director Clinical Research- Alzheimers Disease

Company name
Eisai Inc.

Location
Woodcliff Lake, NJ, United States

Employment Type
Full-Time

Industry
Executive, Manager, Pharmaceutical, Clinical Research

Posted on
Oct 08, 2021

Valid Through
Jan 21, 2022

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Profile

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 isintended fora dynamic individual with clinical leadership experience in the pharmaceutical industry. This role will provide the organization with a qualified individual to design and oversee the conduct of clinical studies for late phase development of acompound for Early 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 Business Group. Essential Functions oAssisting the project team clinical lead in planning, implementation, managing and reporting of CDPs and programs. oDeveloping Clinical Protocols to meet the objectives of the CDP. oServing as a Study Director for selected trials and delivering final protocol, implementation strategy and clinical data review plans. oDepending 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. oIdentifying, monitoring, and resolving clinical program/trial issues, and reporting progress to management. oServing 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. oInterpreting study data and developing integrated summaries of safety and efficacy. Requirements oMD/PhD; MD candidates with 3 years of industry clinical research experience in Neuroscience, preferably Dementia and/or Alzheimer's Disease or PhD candidates with 5 years in clinical research in the pharmaceutical industry, preferably with experience in Neuroscience focused on Dementia and/or oA thorough understanding of clinical research methodology including study design, protocol writing, CRF preparation, and Clinical Study Report preparation oExperience directing late stage development studies; Regulatory filing experience a plus oWorking knowledge of currently available clinical technologies and assessment tools, and drug mechanisms of action. oKnowledge of GCP and local regulatory requirements. oWorking knowledge of the IND/NDA/CTA/MAA processes acquired through direct industrial experience. oKnowledge of medical, scientific, and clinical research techniques in the neurology/psychiatry therapeutic area. oKnowledge of the role of biomarkers and neuroimaging in evaluating pharmacodynamic effects and proof-of-pharmacology. oEisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under state law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine due to a medical condition (including p regnancy-related), or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation. 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: E-Verify Participation Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai’s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, p regnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law. Eisai is an Equal Opportunity Employer - Minority / Female / Disability / Vet

Company info

Eisai Inc.
Website : https://www.eisai.com

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