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IQVIA Director Clinical Medical Research Phase I Medtech in Overland Park, Kansas

OB SUMMARY:

The IQVIA Early Clinical Development (ECD) Medical Director supports early phase opportunities in patients and healthy subjects across all therapeutic areas. We are searching for an experienced and enthusiastic individual to join our team.

The Medical Director is an individual with firsthand knowledge and expertise in the design and conduct of early phase trials. The key remit of the role is to drive growth of the portfolio through scientific and clinical expertise. The position will be charged with using his/her clinical, scientific, and operational knowledge to develop innovative, early phase designs, improving safety, advancing scientific knowledge and decision making. The Medical Director will provide senior clinical and scientific early phase expertise to all IQVIA divisions and will collaborate closely with therapeutic area teams to develop integrated strategies for ECD studies.

The Medical Director will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in their early clinical development plans. As a subject matter expert in ECD, the Associate Medical Director / Medical Director will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community.

RESPONSIBILITIES

Medical Monitoring:

· Primarily serves as 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.

· 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:

· May contribute to the development of the medically related section of client proposals, including the budgeting process.

· May provide medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, protocol feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.

· May attend and present at bid defense meeting, as required.

· Maintains awareness of industry development.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

· 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.

· Good communication, presentation and interpersonal skills, including good command of English language (both written and spoken).

· Ability to establish and maintain effective working relationships with coworkers, managers and clients.

· Skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

· A 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, in addition to 2 years' clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry. Specialty Board certification desirable; or equivalent combination of education, training and experience. The successful Candidate would be a licensed physician in the State of Kansas.

PHYSICAL REQUIREMENTS

· May require frequent travel.

· Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

· Extensive use of keyboard requiring repetitive motion of fingers.

· Regular sitting for extended periods of time.

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 jobs.iqvia.com .

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

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.

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