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.
The potential base pay range for this role, when annualized, is $154,900.00 - $431,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
