Medical Director - Gastroenterology

IQVIA•Durham, NC

10d

About The Position

The Medical Director - Gastroenterology provides medical, clinical, and scientific advisory expertise to IQVIA divisions as requested. The role participates in medical science activities on assigned trials, serves as a medical expert throughout project delivery, and provides therapeutic and medical expertise to business development activities. The position primarily serves as a Global Medical Advisor on assigned projects and as a Scientific Advisor to Project Leaders on medical and scientific matters. It also provides medical support to investigative sites and project staff on protocol-related issues, including protocol clarifications, inclusion and exclusion determinations, and patient safety or eligibility concerns. The role reviews protocols, Investigative Drug Brochures, Case Report Forms, trial-related adverse events, adverse event coding, Clinical Study Reports, and patient narratives. It may also review Serious Adverse Events and support Analysis of Similar Events in collaboration with Pharmacovigilance. Additional activities include therapeutic-area training for clinical teams, attending and presenting at Investigator Meetings, and participating in project and client meetings as needed. The position requires availability 24 hours a day, 7 days a week to respond to urgent protocol-related issues at investigative sites, and may require regular travel.

Requirements

Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at investigative sites.
Excellent communication, presentation, and interpersonal skills, including command of written and spoken English.
Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
Mandatory certification in Gastroenterology.
Specialty Board certification.
At least 5 years of clinical medicine experience, 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 the scientific, clinical, regulatory, commercial, and competitive landscape in the applicable therapeutic area.
Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
Excellent consultation and advisory skills across multiple assignments, as well as initiative and flexibility.
Extensive keyboard use requiring repetitive finger motion.
Extensive telephone and face-to-face communication requiring accurate perception of speech.

Responsibilities

Serve primarily as Global Medical Advisor on assigned projects.
Advise Project Leaders on the medical and scientific aspects of assigned projects.
Provide medical support to investigative sites and project staff on protocol-related issues, including clarifications, inclusion and exclusion determinations, and patient safety or eligibility issues.
Review protocols, Investigative Drug Brochures, and Case Report Forms.
Review and clarify trial-related adverse events.
Provide therapeutic-area and indication training for project clinical teams.
Attend and present at Investigator Meetings.
As needed, review Serious Adverse Events, including case documentation and patient narratives, in collaboration with Pharmacovigilance.
As needed, provide medical support for Analysis of Similar Events in collaboration with or on behalf of Pharmacovigilance.
As needed, review adverse event coding.
Review Clinical Study Reports and patient narratives.
Attend Kick-Off meetings, weekly team meetings, and client meetings as needed or requested.
Provide medical, clinical, and scientific advisory expertise to IQVIA divisions as requested.
Participate in medical science involvement on assigned trials and provide therapeutic and medical expertise to business development activities.