Job Description

Therapeutic Strategy has an exciting opportunity within Oncology/HematologyLet your career soar with IQVIA!

The Sr 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.

RESPONSIBILITIES:

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)

QUALIFICATIONS:

• 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 time (40 hours per week)

• -Full home based position.

• -May require travel (10/20%)

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.