Medical Director – Gastroenterologist

IQVIA•Durham, NC

1d•Remote

About The Position

The Medical Director will provide medical, clinical and scientific advisory expertise to all IQVIA divisions as requested. Participate in all aspects of Medical Science involvement on assigned trials. Serve as medical expert during Project delivery lifecycle. Provide therapeutic and medical expertise to business development activities. Essential Functions The role includes predominantly Medical Monitoring responsibilities with Medical Strategic input involvement as requested. Medical Monitoring: Primarily serves as Global and /or Regional 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). Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. Available to respond to urgent protocol-related issues at the investigative sites. Medical Strategy: Provides expert advise 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. Attends and presents at bid defense meeting, as required. Participates in strategic business development activities including presentations to prospective clients. Requires 5% periodic regional and international travel.

Requirements

Specialty Board certification in Gastroenterologist.
medicine is required.
Candidate will have a minimum 1 year clinical trials experience as medical /clinical expert in the Pharma, CRO, or Biotech industry.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Responsibilities

Provide medical, clinical and scientific advisory expertise to all IQVIA divisions as requested.
Participate in all aspects of Medical Science involvement on assigned trials.
Serve as medical expert during Project delivery lifecycle.
Provide therapeutic and medical expertise to business development activities.
Serve as Global and /or Regional Medical Advisor on assigned projects.
Serve as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects.
Provide 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.
Perform medical review of the protocol, Investigative Drug Brochure (IDB),and/or Case Report Forms (CRFs).
Provide therapeutic area/indication training for the project clinical team.
Attend and present at Investigator Meetings.
Perform review and clarification of trial-related Adverse Events (AEs).
Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
Provide expert advise 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.
Attend and present at bid defense meeting, as required.
Participate in strategic business development activities including presentations to prospective clients.