Associate Medical Director - Endocrinologist

Associate Medical Director - Endocrinologist

IQVIA

Home-based

Job Overview

The Associate Medical Director will provide medical, clinical, and scientific advisory expertise to all IQVIA divisions as requested by her/his LM. 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

Medical Monitoring:

• Primarily serves as Medical Advisor on assigned projects.
• Acts as a primary point of contacts for the Medical Team
• Acts as the primary point of contact for site’s personnel and clinical operation teams.
• 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).
• 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.
• Available 24 hours per day, 7 days per week to respond to Emergent protocol-related issues at the investigative sites.
• May require periodic travel.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Coordinates the medical team involved in the study.
• Coordinates the budget of the medical function.

Qualifications & Requirements

• Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with an active medical license.
• Holds a minimum of 5 years' experience in clinical medicine after residency.
• Specialty Board certification required in Endocrinology.
• Experience in cardiology.
• Nice to have 4 years' 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.

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