Director Medical Neurology Quintiles Tokyo

Job Description
The Director participates in all aspects of Medical and Scientific Services' involvement on assigned trials. Assists in the implementation of department mission, goals and objectives, oversight of operations, development of policies and procedures and standards for the department.

RESPONSIBILITIES
 Serves as Regional Medical Advisor but may also serve as Global Medical Advisor on select projects.

 Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
 Performs review and clarification of trial-related Adverse Events (AEs).
 Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative.
 Provides medical support for the Analysis Of Similar Events (AOSE).
 Performs medical review of Adverse Event coding.
 Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
 Performs review of the Clinical Study Report (CSR) and patient narratives.
 Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.
 Attends and presents at Investigator Meetings.
 Provides therapeutic area/indication training for the project clinical team.
 Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
 Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects.
 Participates in management level meetings within Medical and Scientific Services.
 Provides support to the proposal development team which may include, but is not limited to, reviewing the protocol for feasibility, giving guidance as to anticipated enrollment, and general advice as to the various risks associated with running a particular study.
 Participates in development of Medical and Scientific Services portion of client proposals including the budgeting process.
 Serves as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Medical & Scientific Services.

Required Knowledge, Skills And Abilities

Flexibility to give medical support in other therapeutic areas

Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to regulatory affairs

Ability to establish and meet priorities, deadlines, strategic department goals and objectives.

Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.

Ability to establish and maintain effective working relationships with coworkers, managers and clients

Minimum Required Education And Experience

A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the country or region in which he/she resides and works is required, plus a minimum of 5 years' experience in clinical medicine, in addition to 4 years' clinical development experience in the Pharma, CRO, or Biotech industry. Specialty Board certification desirable; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
 Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
 Extensive use of keyboard requiring repetitive motion of fingers..
 Regular sitting for extended periods of time.
 Frequent travel.

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