Medical Director, US Medical Affairs - Alzheimer's Disease

Responsibilities

• 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.
• Captures and provides reporting information for reports submitted to the regulatory agencies.
• Makes sure protocols are adhered to 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.

Qualifications

• Contributes to the development of medical strategy for major products and/or indications and provides critical medical input into the lifecycle management strategies in responsible therapeutic areas.
• Serves as a medical leader and subject matter expert for relevant external (HCPs, strategic alliances etc.) and internal stakeholders.
• Serves as a medical expert to provide direction for assigned products on key internal business processes including active participation in relevant medical review committees.
• Works with key internal stakeholders to support development and communication of medical plans for the therapeutic area and tracks progress for reporting.
• Seeks all relevant approvals of medical and scientific content for assigned therapeutic areas.
• Incorporates insights from scientific trends and treatment landscape by participating in external events and activities.
• Liaises with external stakeholders to solicit feedback and strengthen Eisai’s medical reputation in the disease state community.
• Manages financial planning/forecasting and budget management, vendor management, timeline development & tracking, and assesses resource needs for respective program(s) within scope of work.
• Manages talent within own area in terms of goal setting, performance management, development, and engagement.