Medical Director - (1723148) in Shanghai, CN at IQVIA™

Date Posted: 6/11/2018

Job Snapshot

Job Description

At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.
At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.
As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.
 
Description
 
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.
The role includes both Medical Monitoring responsibilities and Medical Strategic inputs. The function that should represent the primary focus will be communicated.
Medical Monitoring:
  • Primarily serves 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.
Medical Strategy:
  • Provides expert advises to the development of medically sounded delivery strategies for small to large and/or complex multi-region studies in partnership with sales and other functions responsible for business development activities.
  • Responsible for the development of the medically related aspects of client proposals including the budget related to medical monitoring.
  • Provides medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
  • Attends and presents at bid defense meeting, as required.
  • Participates in strategic business development activities including presentations to prospective clients.
  • Maintains awareness of industry development and may author related publications.
  • May serve as Regional/Multiregional/Global Therapeutic Lead for specific indication(s).


Job Requirements

Qualifications
 
  • Robust and 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.
  • Strong communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
  • Business Acumen.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
  • 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 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.
 
If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team
 
Connect to great opportunity™
 
Quintiles is a strong advocate of diversity and inclusion in the workplace.  We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success.  We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential.
 
Did You Know?
  • Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015
  • Quintiles has 36,000 employees conducting business in more than 100 countries
  • Quintiles was named to FORTUNE’s World’s Most Admired Companies®2016 list
  • Quintiles was named as a 2016 World’s Most Ethical Company® by the Ethisphere Institute
* Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015
* Quintiles has 36,000 employees conducting business in more than 100 countries
* Quintiles was named to FORTUNE’s World’s Most Admired Companies® 2016 list
* Quintiles was named as a 2016 World’s Most Ethical Company® by the Ethisphere Institute

Job ID: 1723148