Oncology/Hematology Medical Executive

2 settimane fa

Milano, Lombardia, Italia IQVIA A tempo pieno

Position Overview

The medical division is composed of a Chief Medical Officer, Medical Directors, medical writers, and safety associates. The Medical Director is responsible for providing medical and scientific expertise to clinical research initiatives, study teams, and investigators. This role also involves offering guidance, review, and leadership for clinical research programs that are either proposed or awarded.

The Medical Director operates as a collaborative team member and reports in a matrix structure to project teams, similar to other project team members. The primary responsibility of the Medical Director is to ensure medical oversight for clinical trials by acting as the Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor organizations. The Medical Monitor serves as the main contact for the sponsor's medical team and acts as the primary medical resource to support the project team. This role is typically available around the clock to address inquiries from site coordinators and investigators regarding protocol criteria, clarifications, compliance issues, and to review alert labs as per sponsor preferences. Key responsibilities of the Medical Director include:

Core Responsibilities


• Project Team Participation

- Provide medical and scientific contributions to clinical research programs, including the evaluation of new business proposals, preclinical and clinical data, study protocols, training materials, informed consent documents, Investigator Drug Brochures, electronic Case Report Forms (eCRFs), analysis plan designs, clinical study reports, regulatory submissions, and adverse event evaluations.

- Ensure that medical activities adhere to Good Clinical Practice (GCP) and operate with maximum efficiency.

- Establish and maintain a network of medical and scientific consultants.

- Supervise and oversee the activities of Medical Directors.


• Clinical Responsibilities:

- Engage with clients regarding drug development programs, study design, and protocols.

- Review and provide feedback on protocol development. Collaborate with key thought leaders and sponsor representatives to establish inclusion/exclusion criteria and study endpoints. Work in a team-oriented manner to develop statistical and data management sections of the protocol. Review the final protocol for clinical, safety, and efficacy parameters.

- Conduct training for project teams on protocols and therapeutic areas.

- Assist in developing criteria for investigator site selection and network potential investigators for study involvement.

- Participate in subject recruitment and retention efforts, including direct outreach to key opinion leaders, investigators, and site staff, as well as involvement in teleconferences and presentations.

- Present protocol and safety reporting information at investigator meetings.

- Develop project medical monitoring plans as required.

- Provide on-call support for protocol inquiries and site assistance. Serve as the first point of contact for investigators and monitors regarding study-related medical and safety concerns and the resolution of protocol and patient eligibility issues.


• Safety Monitoring and Adverse Event Reporting:

- Ensure the medical accuracy of patient safety data and maintain an ongoing evaluation of the study's safety profile.

- Conduct medical reviews of Serious Adverse Event (SAE) reports, draft and/or review SAE narratives, and collaborate with the Safety Management Department to track SAEs and follow up on outstanding safety queries, engaging with sponsors as necessary.

- Review IND/SUSAR Safety Reports, updates to Investigator Brochures, and annual IND reports containing sponsor data.

- In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments.

- Interact with relevant FDA officials regarding safety and other study-related matters, as required.


• Data Management Responsibilities:

- Provide medical review of eCRFs for clinical accuracy.

- Conduct medical reviews of data analysis plans.

- Review safety fields at case freeze for reconciliation, if necessary.

- Collaborate with the data group to reconcile SAE events as needed.

- Review medical coding of adverse events, laboratory data, and concomitant medications for accuracy and consistency.

- Review data tables, listings, and figures.

- Review and/or compose sections of the final clinical study report.


• DSMB/Adjudication Committee Responsibilities:

- Assist sponsors in selecting committee members.

- May serve as a non-voting member to convene and organize proceedings.

- Develop operating guidelines in collaboration with committee members and submit these to sponsors for review.

- Ensure accurate data flow with sponsors for reporting purposes.

- Facilitate feedback from DSMB to sites for Institutional Review Boards (IRBs).


• Business Development Contributions:

- Collaborate with Business Development to actively pursue new business opportunities, including support for marketing presentations and proposal development.

- Contribute to business development efforts through proposal development and sales presentations.

- Engage in feasibility discussions related to specific project proposals.


• Special Projects:

- Conduct literature searches to gather background information for study proposals, prepare training sessions, and interpret clinical data.

- Assist in drafting standard operating procedures and working practices related to all Medical Director activities.

- Participate in various team quality improvement initiatives as necessary.

- Perform other related duties as assigned by the Chief Medical Officer.

Qualifications

- Medical Degree from an accredited and internationally recognized medical institution with a curriculum relevant to general medical education.

- A minimum of 10 years of experience is required, which may include medical practice (hospital/clinic), academia, clinical research, or drug development.

- 3-5 years of biopharmaceutical industry experience is preferred and can be part of the 10-year experience.

- Ability to collaborate effectively with a multidisciplinary team, translating concepts into practical approaches and fostering consensus.

- Exceptional ability to work independently with minimal supervision, while also being effective within a team and matrix environment.

- Capacity to organize and manage multiple projects, each with specific requirements and shifting priorities.

- Excellent oral and written communication skills, along with strong interpersonal skills, are essential.

Specializations: Oncology; Hematology;

- Current or prior medical practice license; board certification/eligibility is preferred.

- Board Certified / Board Eligible: Oncology/Hematology (Required).

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are committed to pushing the boundaries of human science and data science to create a significant impact, helping our clients build a healthier world. Learn more at

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