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发帖数: 1 | 1 Medical Director, Oncology (China)
Quintiles is the world’s leading provider of biopharmaceutical services.
With a network of more than 28,000 employees conducting business in
approximately 100 countries, we have helped develop or commercialize all of
the top 50 best selling drugs on the market. With extensive therapeutic,
scientific and analytics expertise, we help biopharmaceutical and health
sciences customers navigate the increasingly complex landscape with more
predictability to enable better outcomes. We are now looking for an
Oncology expert to join us as a Medical Director, Oncology to be based in
our China office.
The Medical Director, Oncology participates in all aspects of Medical and
Scientific Services' involvement on assigned trials in the Oncology arena.
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.
All responsibilities are essential job functions unless noted as
nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• 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
• An Oncology or related equivalent 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
If you’re interested to be part of the excellent Quintiles family, please
reach out or write in to our Staffing Manager – Sabrina Teo at Sabrina.teo@
quintiles.com |
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