Descripción de la oferta
Overview
In this role you will provide senior medical leadership in oncology/hematology, combining hands-on medical monitoring with portfolio-level medical oversight to uphold scientific credibility for sponsors. You will ensure medical input across study designs, safety reviews, and regulatory documents, while supporting business development and sponsor engagement. You’ll shape medical strategy for the oncology portfolio and represent the company at scientific forums. This position offers a chance to influence clinical development at scale within a collaborative, innovation-driven team.
Compensaciones / Beneficioscompetitive compensation packagecomprehensive benefitsopportunity for personal and professional growthcollaborative and innovative environment
ResponsabilidadesAct as medical monitor for assigned oncology studies and oversee protocol-related medical reviews and safety data interpretationProvide escalation-level medical oversight across the oncology portfolio and advise on study design and measurementsReview safety components of protocols, Investigators Brochure, and clinical trial reports from a safety perspectiveAssess adverse events (AEs/SAEs) and contribute to PSURs, PBRERs, DSURs, and Risk Management PlansContribute to regulatory documents and literature review; participate in SOP development and staff educationRepresent the company as a senior scientific voice in targeted indications; engage with KOLs and investigatorsBuild and maintain sponsor relationships, support bid strategy and defense meetings, and translate science into credible sponsor messagingCoordinate with Business Development and leadership teams to shape oncology strategy and service offering
Requisitos principalesMD with specialist medical training10+ years of post-qualification medical experience7+ years in oncology/hematology clinical developmentHands-on medical monitor experience in oncology trialsExperience on safety data review boards or equivalentUnderstanding of ICH, GCP, Pharmacovigilance, and internal SOPsExcellent written and verbal communication; able to work in fast-paced, international environmentWillingness to travel internationallyexcellent communicationability to work in a fast-paced environmentstakeholder managementmedical monitoring in oncology trialssafety data reviews (AEs/SAEs)PSURs, PBRERs, DSURs
