Medical Director- Oncology / Hematology (Home-Based)

Buscojobs; Lombardia; In loco; EUR 90.000 - 140.000; Tempo pieno

Descrizione del lavoro

A leading firm in clinical research is looking for a Medical Director to oversee clinical trials and ensure compliance with guidelines. This role requires a strong medical background, with the ability to lead multidisciplinary teams and manage multiple projects, focusing on the development and safety of new medical treatments. Ideal candidates will have extensive experience in clinical research, particularly in oncology or hematology, and possess excellent communication skills.

Competenze

• Minimum 10 years of experience in medical practice, clinical research, or drug development.
• 3-5 years of industry experience preferred.
• Oncology or Hematology expertise is advantageous.

Mansioni

• Oversee clinical trials as Medical Monitor, ensuring compliance with GCP.
• Provide medical input on clinical research proposals and data.
• Develop medical monitoring plans and support safety monitoring.

Conoscenze

Collaboration

Communication

Leadership

Formazione

Medical Degree

Descrizione del lavoro

The medical department includes a Chief Medical Officer, Medical Directors, medical writers, and safety associates. The Medical Director provides medical and scientific support to clinical research programs, study teams, and investigators. This role offers review, advice, and leadership for clinical research programs.

The Medical Director functions as a team member within a matrix reporting structure, similar to other project team members. The primary responsibility is to oversee clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The Medical Monitor acts as the main contact for the sponsor medical team and a frontline resource supporting the project team, available 24/7 to address questions related to protocol criteria, clarifications, compliance, and review of alert labs as per sponsor preferences. Major duties include:

Essential Functions

• Project Team Member: Provide medical and scientific input on clinical research programs, including review of proposals, data, protocols, training materials, consent forms, Investigator Drug Brochures, eCRFs, analysis plans, reports, and regulatory submissions.
• Ensure medical activities comply with GCP and operate efficiently.
• Establish and maintain a network of medical/scientific consultants.
• Supervise and manage Medical Director activities: interact with clients regarding drug development, study design, and protocol development.
• Review and input into protocols, develop inclusion/exclusion criteria, and study endpoints.
• Train project teams on protocols and therapeutic areas.
• Assist in investigator site selection and networking.
• Participate in recruitment and retention activities, investigator meetings, and safety reporting.
• Develop medical monitoring plans and provide on-call support for safety issues.
• Safety Monitoring and SAE Reporting: verify safety data accuracy, review SAE reports, and liaise with Safety Management.
• Review IND/SUSAR reports, update brochures, and follow safety procedures.
• Interact with FDA officials as needed.
• Data Activities: review eCRFs, data analysis plans, and safety data reconciliation.
• Review adverse event coding, data tables, and final reports.
• DSMB/Adjudication Committee Activities: assist in committee member selection, organize proceedings, develop guidelines, and ensure data flow accuracy.
• Ensure DSMB feedback is provided to sites for IRBs.
• Business Development: support proposal development, marketing, and feasibility discussions.
• Special Projects: conduct literature searches, assist in report writing, and draft SOPs.
• Participate in team quality improvements and other duties as assigned by the CMO.

Qualifications

• Medical Degree from an accredited medical school relevant to general medicine.
• Minimum 10 years of experience in medical practice, academia, clinical research, or drug development.
• Preferred 3-5 years of industry experience, possibly within the total experience.
• Ability to collaborate across multidisciplinary teams and promote consensus.
• Proven ability to work independently and efficiently manage multiple projects.
• Excellent communication and interpersonal skills.
• Oncology or Hematology expertise is advantageous.
• Current or prior medical license; board certification or eligibility preferred.

IQVIA is a leading provider of analytics, technology, and clinical research services, committed to advancing human and data science to improve global health. Learn more at (website).

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