Woodcliff Lake, NJ, United States
Clevel, Executive, Research, 100k
May 28, 2020
Sep 10, 2020
Job Description: The Vice President Clinical Research incumbent will provide direct oversight as the subject matter expert to all neurology clinical development activities as it pertains to our epilepsy and sleep therapeutic areas. The ideal candidate will be a seasoned professional with broad experience in all phases of clinical development, having a successful track record in the development, submission and ultimate approval of multiple NDAs of related compounds. This is a leadership position requiring exceptional skills in leading and developing personnel, strategic expertise in managing drug development plans and growing portfolios, effective communication skills across multiple audience populations including administrative agencies and business partners etc. The incumbent must demonstrate great flexibility and willingness to adjust responsibilities and priorities across therapeutic areas as needed and may at times, be required to function as an International Project Team Leader. It is essential that qualified individual possess Medical Doctor credentials. Responsibilities include but are not limited to: * Designing and providing insight to 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 contractors 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 Qualifications and Experience: * 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 specific to Epilepsy and / or Sleep Clinical Development Plans a plus * A thorough understanding of clinical research methodology including study design, protocol writing and study report preparation * Knowledge of medical, scientific & clinical research techniques in the neurology area * Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industry experience 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: Right To Work E-Verify Participation
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