Medical Director, Cardiology

About the role

The Associate Medical Director / Medical Director 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 as requested.

Responsibilities

• Primarily serves as Global and /or Regional 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).
• 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.
• 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 24/7 to respond urgent protocol -related questions from investigative sites, in accordance with local labor laws.

Qualifications

• Board certification in Cardiology.
• Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to the specific therapeutic area, plus a minimum of 5 years' experience in clinical medicine post residency period.
• Typically requires 5 - 7 years of prior relevant experience in the requested medical specialty area; In addition, previous clinical research experience as an investigator or in the Pharma, CRO, or Biotech industry is required.
• Experience in Clinical Development (Phase I -IV)
• Previous experience in cardiology with exposure to metabolic disease indications is preferred.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Strong communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
• Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
• Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
• Current or prior license to practice medicine.