Associate Medical Director / Medical Director, Oncology / Hematology (Home-based) (R1087316) in Durham, NC at IQVIA™

Date Posted: 8/8/2019

Job Snapshot

  • Employee Type:
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Therapeutic Strategy has an exciting opportunity within Oncology/Hematology.  Let your career soar with IQVIA!

The Medical Monitor 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.


The role includes both Medical Monitoring responsibilities and Medical Strategic inputs. The function that should represent the primary focus will be communicated.

Medical Monitoring:

•Primarily serves as Global Medical Advisor on oncology and/or hematology clinical studies.
•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:

•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.
•Participates in strategic business development activities including presentations to prospective clients.
•Maintains awareness of industry development and may author related publications.
•May serve as Regional/Multi-regional/Global Therapeutic Lead for specific indication(s)


•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.
•Board Certification in Oncology and/or Hematology.
•Fluent English.
•Minimum 5 years of CRO and /or Pharma industry experience with a Medical Director grade or similar, in addition to experience as Clinical investigator in clinical studies over some years (desirable).
•Proven skills & abilities:
-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.

-Team orientation. Strong communication, presentation and interpersonal skills.

-Business Acumen.

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

-Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.

Work conditions:

-Full home based position.

-May require travel (10/20%)

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

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 to arrange for such an accommodation.

Job ID: R1087316