Medical Director - Gastroenterology

Job Title: Medical Director - Gastroenterology

Job Location: Durham, North Carolina, United States of America

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Job Overview The Medical Director - Gastroenterology 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 a medical expert during project delivery lifecycle; provide therapeutic and medical expertise to business development activities.

Essential Functions - 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).

• Performs review and clarification of trial-related Adverse Events (AEs). - Provides therapeutic area/indication training for the project clinical team. - Attends and presents at Investigator Meetings. - 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.

Requirements - Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.

- May require regular travel.

• Extensive use of keyboard requiring repetitive motion of fingers. - Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

Qualifications

• Excellent communication, presentation and interpersonal skills, including the command of English language (both written and spoken).
• Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. - Certification in Gastroenterology (mandatory) - Specialty Board certification required. - At least 5 years of experience in clinical medicine in addition to 4 years of clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry. - 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.
• Excellent skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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