Medical Director - Oncology, Sponsor Dedicated (Home-Based)

About the role

The Medical Director provides medical and scientific support to clinical research programs, study teams and investigators, and gives review, advice and leadership to potentially or awarded programs. The role is a team-member position that reports through a matrix to project teams, and acts as Medical Monitor for studies run by IQVIA Biotech Clinical on behalf of sponsor companies. It is a home-based, sponsor-dedicated position in Warsaw.

Key responsibilities

• Provide medical and scientific input to clinical research programs, including protocols, informed consent, eCRFs, analysis plans, clinical study reports, regulatory submissions and adverse event evaluation.
• Ensure medical activities comply with GCP and supervise Medical Director activities.
• Review protocols, interact with sponsors and thought leaders on inclusion/exclusion criteria and endpoints, and train the project team.
• Help with site selection, subject recruitment and retention, and present protocol and safety information at investigator meetings.
• Develop medical monitoring plans and provide on-call coverage for protocol queries and site support.
• Review SAE reporting, write and review SAE narratives, and review IND/SUSAR reports and annual IND reports.
• Review eCRFs, data analysis plans, adverse event coding and data tables, and contribute to the final clinical study report.
• Support DSMB activities, business development and special projects such as literature searches and SOP drafting.

Required profile

• Medical degree from an accredited, internationally recognized medical school.
• 10 years of experience, which can include hospital/clinic practice, academia, clinical research or drug development; 3-5 years of biopharmaceutical industry experience is preferred.
• Oncology board certification or board eligibility (required); urology or surgical oncology preferred.
• Ability to work independently, in a team and in a matrix environment, and excellent communication skills.