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Executive Director, Clinical Research - Alzheimer's Disease

Eisai Inc.


Location:
Woodcliff Lake, NJ
Date:
04/24/2018
2018-04-242018-05-24
Job Code:
4294BR
Eisai Inc.
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Job Details

Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. Eisai recognizes that we are the Company’s greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests. The Executive Director, Clinical Research will provide direct support as a Subject Matter Expert to various compounds & programs related to the Alzheimer's Disease therapeutic area. Dependent upon specific projects or compounds, the incumbent may function as a International Project Team Leader. It is essential that qualified individuals possess Medical Doctor credentials. Responsibilities include but are not limited to: - Designing and providing insight of clinical research plans and programs to include the integrated regulatory and biomarker strategies - Leading the development and execution of the CDP and DDP - Leading the development of Clinical Protocols to meet CDP objectives - Overseeing and resolving operational aspects of clinical studies in conjunction with project and study teams and in accordance with SOP, GCP and regional regulations - Reviewing and Monitoring safety data from a clinical program and identifying trends and signals -Developing strategies to identify, monitor and resolve clinical program/trial issues - Serving as SME to management for the (marketing or research functions) and regulatory agencies, sets strategy for Advisory Boards, and builds strong relationships with KOLs - Interpreting study data and developing integrated summaries of safety and efficacy - Providing scientific leadership for regulatory documents creation (e.g., briefing books, NDAs etc.) - Representing Clinical in discussions with Health Authorities - Integrating and implementing new resources (tools, systems, vendors, etc) and techniques with existing ones - Setting overall deadlines for projects within function and tracking project milestones - Managing contractions or ensuring that contractors, consultants and vendors complete assigned work according to agreed timelines. - Making appropriate budgetary allocations to targeted opportunities - Championing effective coaching and development planning in a way that fosters a culture of proactive people in development at Eisai - Participating in the recruitment, selection, performance, and succession planning activities Job Requirements: - MD required, Board Certification in a related area preferred. - 12+ years of experience in pharmaceutical clinical development, with - experience directing Neurology Phase 2-3 global multicenter studies - Experience in Alzheimer's Clinical Development a plus - A thorough understanding of clinical research methodology including study design, protocol writing and study report preparation - Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industry experience - Knowledge of medical, scientific and clinical research techniques in the Neurology area Job Requirements: - MD required, Board Certification in a related area preferred. - 12+ years of experience in pharmaceutical clinical development, with - experience directing Neurology Phase 2-3 global multicenter studies - Experience in Alzheimer's Clinical Development a plus - A thorough understanding of clinical research methodology including study design, protocol writing and study report preparation - Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industry experience - Knowledge of medical, scientific and clinical research techniques in the Neurology area Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs. 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, pregnancy, 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 from tblHiringOrgDefaults
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