Medical Advisor/Associate Medical Director (Shanghai, Beijing)
Provide medical, clinical and scientific advisory expertise to all Quintiles divisions as requested. Participate in all aspects of Medical Science involvement on assigned trials. Serve as a medical expert during project delivery lifecycle. Provide therapeutic and medical expertise to business development activities, as needed.
Primarily serves as Regional Medical Advisor but may serve as Global Medical Advisor on assigned projects.
- Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned 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 medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
- Provides therapeutic area/indication training for the project clinical team.
- Attends and presents at Investigator Meetings.
- Performs review and clarification of trial-related Adverse Events (AEs).
- May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
- May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
- May perform medical review of adverse event coding.
Performs review of the Clinical Study Report (CSR) and patient narratives.
- Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
- Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.
May contribute to the development of the medically related section of client proposals, including the budgeting process.
- May provide medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, protocol feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
- May attend and present at bid defense meeting, as required.
- Maintains awareness of industry development.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
- Good communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
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 2 years' clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry. Specialty Board certification desirable; or equivalent combination of education, training and experience.