Medical Director - Oncology, Sponsor Dedicated (12-Month Fixed Term)

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. This is a 12-month fixed-term contract, sponsor dedicated, acting as Medical Monitor for studies run by IQVIA Biotech Clinical on behalf of sponsor companies. The role is a team-member position within a matrix structure, reporting to project teams.

Key responsibilities

• Provide medical oversight of clinical trials: review proposals, protocols, informed consent, eCRFs, analysis plans, clinical study reports, regulatory submissions and adverse event evaluations.
• Ensure medical activities comply with GCP and act as the first-line medical resource for sponsors, site coordinators and investigators, including 24/7 availability for protocol and eligibility questions.
• Review and advise on protocol development, study endpoints, inclusion/exclusion criteria and statistical and data management sections; train the project team and help select investigators.
• Verify the medical accuracy of safety data, review SAE reporting and 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/adjudication committee activities, including data flow and feedback to sites.
• Assist business development with proposals and presentations, and take part in special projects such as literature searches, SOPs and quality improvement.

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 multidisciplinary team and across several projects, with excellent communication skills.