Medical Director, US Medical Affairs - Alzheimer's Disease

Eisai•Nutley, NJ

2d•$217,000 - $284,800

About The Position

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. Oversees the direction, planning, execution, clinical trials/research and the data collection activities. Contributes to implementation of clinical protocols, and facilitates completion of final reports. Recruits clinical investigators and negotiates study design and costs. Responsible for directing human clinical trials, phases III? IV for company products under development. Participates in adverse event reporting and safety responsibilities monitoring. Coordinates and provides reporting information for reports submitted to the regulatory agencies. Monitors adherence to protocols and determines study completion. Coordinates and oversees investigator initiations and group studies. May participate in adverse event reporting and safety responsibilities monitoring. May act as consultant/liaison with other corporations when working under licensing agreements. The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive tactics for Alzheimer's Disease. The Medical Director oversees the planning and execution of real-world evidence and data generation activities. The incumbent contributes to the Medical Affairs plan and provides ongoing training and mentoring to Associate Directors. This role will be responsible for working with key stakeholders to develop and execute the medical affairs plan, including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plan. A critical component of this role will be to provide strategic development, planning, implementation and oversight of real-world studies within the Medical Affairs department for products in the therapeutic area. The Medical Director will utilize expert medical/scientific knowledge in assigned therapeutic area to provide strategic input for the development of product strategies and liaise with external stakeholders to solicit feedback and strengthen Eisai’s medical reputation in the disease state community. This role is responsible for approval of medical and scientific content of all relevant materials/communications.

Requirements

Communication & Cross-functional Influence
Critical Thinking & Business Agility
Healthcare Environment Dynamics
MA Strategic Thinking
Mentoring/ People Development
Resource Planning & Management
Technical Breadth (Medical Affairs)

Responsibilities

Contribute to the development of medical strategy for major products and/or indications and provide critical medical input into the lifecycle management strategies in responsible therapeutic areas.
Plan and implement real-world studies for assigned products.
Serve as a medical leader and subject matter expert for relevant external (HCPs, strategic alliances etc.) and internal stakeholders.
Serve as a medical expert to provide direction for assigned products on key internal business processes including active participation in relevant medical review committees.
Work with key internal stakeholders to support development and communication of medical plans for the therapeutic area and track progress for reporting.
Seek all relevant approvals of medical and scientific content for assigned therapeutic areas.
Incorporate insights from scientific trends and treatment landscape by participating in external events and activities.
Liaise with external stakeholders to solicit feedback and strengthen Eisai’s medical reputation in the disease state community.
Direct and manage financial planning/forecasting and budget management, vendor management, timeline development & tracking, and assess resource needs for respective program(s) within scope of work.
Manage talent within own area in terms of goal setting, performance management, development, and engagement.