Clinical Director

04 ago - Italia
Altro

Experteer OverviewAs 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 / BenefitsProvide medical oversight to ensure GCP, regulatory, and Sponsor directives are followedOffer medical consultation for protocol development and project activitiesServe as point of contact for medical questions and safety-related communicationsDevelop 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 reportsTrain CRAs and team members on medical/safety topics and therapeutic area knowledgeReview SAEs, AESIs,



and safety reports; identify trends and perform risk assessmentPerform medical data reviews to resolve data issues and support regulatory responsesEscalate urgent safety issues to management and coordinate with Safety/PharmacovigilanceCollaborate with cross-functional groups (Data Management, Biostatistics, QA) to ensure medical operations are effectiveContribute to business development activities with medical input for proposals and capability meetingsResponsabilitàMD with specialist training in Medical Oncology, Hematology-Oncology, or related oncology disciplineMinimum 3 years of direct oncology experience; practicing oncologistAt least 5 years of post‐training clinical research experience; CRO experience preferredExperience across medical monitoring activities and safety data reviewsExperience in developing and delivering therapy/ protocol trainingsAbility to represent the company in meetings with sponsors
J-18808-

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