Job OverviewThe Associate Medical Director / Medical Director will provide medical, clinical and scientificadvisory expertise to all IQVIA divisions as requested.
Participate in all aspects of Medical Scienceinvolvement on assigned trials. Serve as a medical expert during project delivery lifecycle.
Providetherapeutic and medical expertise to business development activities.Essential Functions
The role includes predominantly Medical Monitoring responsibilities with Medical Strategic input involvement as requested.
Medical Monitoring :
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 includingprotocol 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 urgent protocol-related issues at the investigative sites.
Medical Strategy :
Provides expert advises to the development of medically sounded delivery strategies for small to large and / or complex multi-region studies in partnership with sales and other functions responsible for business development activities.
Responsible for the development of the medically related aspects of client proposals including the budget related to medical monitoring.
Provides medical and scientific advises to key internal stakeholders developing proposals : this may include, but is not limited to, reviewing the protocol for scientific / regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
Attends and presents at bid defense meeting, as required.
Participates in strategic business development activities including presentations to prospective clients.
Maintains awareness of industry development and may author related publications.
Requires periodic regional and international travel.Qualifications
Other Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the country or region in which he / she resides and works is required, plus a minimum of 5 years' experience in clinical medicine.
Specialty Board certification in Respiratory medicine is required. Req
Ideally, candidate will have a minimum 2 years clinical trials experience as an investigator or medical / clinical expert in the Pharma, CRO, or Biotech industry.
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.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.
Learn more at IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward.
Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health.
Thank you for your interest in growing your career with us.EEO Minorities / Females / Protected Veterans / Disabled