Medical Director - Gastroenterology

IQVIA•Durham, NC

11d•$154,900 - $431,500

About The Position

The Medical Director - Gastroenterology provides medical, clinical, and scientific advisory expertise to IQVIA divisions; participates in medical science activities on assigned trials; serves as a medical expert throughout project delivery; and provides therapeutic and medical expertise for business development. The role primarily serves as a Global Medical Advisor and Scientific Advisor on assigned projects, supporting project leaders and project teams on medical and scientific matters. The position provides medical support to investigative sites and project staff on protocol-related questions, including protocol clarifications, inclusion and exclusion determinations, and patient safety or eligibility issues. It reviews protocols, Investigative Drug Brochures, Case Report Forms, trial-related adverse events, Clinical Study Reports, and patient narratives. The Medical Director may also conduct serious adverse event case reviews with Pharmacovigilance, support Analysis of Similar Events, and review adverse event coding. Additional duties include therapeutic-area training, participation in Investigator Meetings, and attendance at project and client meetings as needed. The role requires availability around the clock to respond to urgent protocol-related issues at investigative sites and may involve regular travel. It requires a medical degree and Gastroenterology specialty board certification, as well as clinical medicine and clinical trials experience. The potential annualized base pay range is $154,900 to $431,500; actual pay may vary based on qualifications, location, and schedule. Depending on the position offered, incentive compensation and other benefits may also be available.

Requirements

Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
Gastroenterology certification is mandatory; specialty board certification is required.
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.
Excellent communication, presentation, and interpersonal skills, including strong written and spoken English.
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, along with initiative and flexibility.
Available 24 hours per day, 7 days per week, to respond to urgent protocol-related issues at investigative sites.
May require regular travel.
Extensive keyboard use requiring repetitive finger motion.
Extensive telephone and face-to-face communication requiring accurate perception of speech.

Responsibilities

Primarily serve as Global Medical Advisor on assigned projects.
Serve as Scientific Advisor and guide 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/exclusion determinations, and patient safety or eligibility issues.
Review protocols, Investigative Drug Brochures (IDBs), and/or Case Report Forms (CRFs).
Review and clarify trial-related Adverse Events (AEs).
Provide therapeutic-area and indication training for project clinical teams.
Attend and present at Investigator Meetings.
As needed, conduct medical case reviews of Serious Adverse Events (SAEs), including case documentation and patient narratives, in collaboration with Pharmacovigilance.
As needed, provide medical support for Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance.
As needed, review adverse event coding.
Review Clinical Study Reports (CSRs) 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 and therapeutic and medical expertise to business development activities.
Participate in medical science activities on assigned trials and serve as a medical expert during project delivery.