Oncology/Hematology Medical Executive

2 settimane fa

Milano, Lombardia, Italia IQVIA A tempo pieno

Position Summary

The medical division is composed of a Chief Medical Officer, Medical Directors, medical writers, and safety associates. The Medical Director plays a crucial role in delivering medical and scientific expertise to clinical research initiatives, study teams, and investigators. This position also involves providing guidance, evaluation, and leadership for clinical research programs that are either proposed or already funded.

The Medical Director functions as a collaborative team member and operates within a matrix reporting structure, similar to other project team members. The primary responsibility of the Medical Director is to oversee medical aspects of clinical trials by acting as the Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsors. The Medical Monitor serves as the main point of contact for the sponsor's medical team and acts as the primary medical resource for the project team. This role typically requires availability around the clock to address inquiries from site coordinators and investigators regarding protocol criteria, clarifications, compliance issues, and to review laboratory alerts as per sponsor preferences. Key responsibilities of the Medical Director include:

Core Responsibilities


• Project Team Involvement

Provide medical and scientific contributions to clinical research initiatives, 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 plans, clinical study reports, regulatory submissions, and adverse event evaluations.

Ensure that medical activities comply with Good Clinical Practice (GCP) and operate with optimal efficiency.

Establish and maintain a network of medical and scientific consultants.

Supervise and manage 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 opinion leaders and sponsor representatives to establish inclusion/exclusion criteria and study endpoints. Work within a team to develop statistical and data management sections of the protocol. Review the final protocol for clinical, safety, and efficacy variables.

Provide training to project teams on protocols and therapeutic areas.

Assist in establishing criteria for investigator site selection and networking for potential investigators for study participation.

Participate in subject recruitment and retention efforts, including outreach to key opinion leaders, investigators, and site staff.

Present protocol and safety reporting information at investigator meetings.

Develop project-specific medical monitoring plans as needed.

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 issues.


• Safety Oversight and Adverse Event Reporting:

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

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

Review IND/SUSAR Safety Reports and updates to Investigator Brochures and annual IND reports.

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 issues as necessary.


• Data Management Activities:

Conduct medical reviews of eCRFs for clinical accuracy.

Review safety fields at case freeze for reconciliation as needed.

Collaborate with the data team to reconcile SAE events.

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

Review data tables, listings, and figures.

Contribute to the final clinical study report.


• DSMB/Adjudication Committee Involvement:

Assist the sponsor in selecting committee members.

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

Develop operating guidelines in collaboration with committee members and submit these for sponsor review.

Ensure accurate data flow with the sponsor for reporting purposes.

Ensure DSMB feedback is communicated 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.

Participate in feasibility discussions related to specific project proposals.


• Special Projects:

Conduct literature searches to gather background information for study proposals, training session preparation, and clinical data interpretation.

Assist in drafting standard operating procedures and working practices for all Medical Director activities.

Engage in various team quality improvement initiatives as necessary.

Perform additional duties as assigned by the Chief Medical Officer.

Required 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, academia, clinical research, or drug development.

Preferred experience includes 3-5 years in the biopharmaceutical industry, which can be part of the 10-year experience.

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

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

Strong organizational skills to manage multiple projects with specific requirements and shifting priorities.

Excellent oral and written communication skills, along with strong interpersonal abilities.

Specialty Areas: Oncology; Hematology;

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

Board Certified / Board Eligible in Oncology/Hematology is 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 in helping our customers build a healthier world. Learn more at

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