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Medical Director, Oncology

Experteer Italy

Experteer Overview

As Medical Director in oncology, you oversee medical monitoring across global trials and support delivery of innovative cancer therapies. You will ensure patient safety, data integrity, and regulatory compliance while collaborating with sponsors and cross-functional teams. Your expertise will shape trial strategies, safety reporting, and medical review across the project lifecycle. This role offers impact on patient outcomes and opportunities to influence development decisions in a global CRO setting.Retribuzione / Benefits

  • Provide medical oversight to ensure GCP, regulatory, and Sponsor directives are followed
  • Offer medical consultation for protocol development and project activities
  • Serve as point of contact for medical questions and safety-related communications
  • Develop and update the Medical Monitoring Plan (MMP) and review the Safety Management Plan (SMP)
  • Review and advise on study protocols, consent forms, and clinical study reports
  • Train CRAs and team members on medical/safety topics and therapeutic area knowledge
  • Review SAEs, AESIs, and safety reports; identify trends and perform risk assessment
  • Perform medical data reviews to resolve data issues and support regulatory responses
  • Escalate urgent safety issues to management and coordinate with Safety/Pharmacovigilance
  • Collaborate with cross-functional groups (Data Management, Biostatistics, QA) to ensure medical operations are effective
  • Contribute to business development activities with medical input for proposals and capability meetings
Responsabilità
  • MD with specialist training in Medical Oncology, Hematology-Oncology, or related oncology discipline
  • Minimum 3 years of direct oncology experience; practicing oncologist
  • At least 5 years of post‑training clinical research experience; CRO experience preferred
  • Experience across medical monitoring activities and safety data reviews
  • Experience in developing and delivering therapy/ protocol trainings
  • Ability to represent the company in meetings with sponsors
#J-18808-Ljbffr
Offerta di lavoro pubblicata 6 giorni fa
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