Requirements: English
Company: The Medical Affairs Company
Regional Medical Director (RMD), Oncology (EU)Tagged : Oncology, Field Medical , Hematology , Pharmaceutical, Director, TMAC, Clinical Research, CardiovascularTerritory includes but not limited to : Multiple EU countriesThe Regional Medical Director (RMD) is an integral member of the oncology clinical sciences group, who assists and extends Clinical Sciences across the oncology portfolio on assigned studies at the regional level.Duties and Responsibilities :Site engagement and trainingA cadence of touchpoints with sites on a regular basis Meeting with sites and presenting at PSVs, SIVsRetraining as needed (., due to amendments)Recruitment issuesSite identification / recruitment : Meeting with potential sites, in collaboration with CTL, to discuss the program / assess of their interestPatient recruitment issues (ongoing oversight) : Meeting with sites, in collaboration with CTL, to help understand the hurdles with recruitment at their site and trouble shootingAnswering questions from sitesHelping address site medical / clinical questions as a first line for those questions that are straightforward or previously addressed or to help coordinate a response with the Medical Director for those that are not straightforward / newThis includes referencing and updating the FAQ, as applicableMedical Director should always be copied on the email correspondence for oversightAssisting with eligibility assessmentsHelp perform eligibility checks or address urgent eligibility questions prior to randomizationAssisting with query closureHelping the site understand what is needed to close a medical query if there is a misunderstanding from the site regarding what is neededFeedback should also be provided to the study team if the query text could be improved for clarityHelping ensure that the information that we must have to describe a safety event is sufficient, including : Ensuring that all information has been gathered as expected (., the site has taken all reasonable steps to obtain the information, in collaboration with the CRA, if additional support is needed during escalation processEnsure that all questions have been answered / follow-up assessments have been doneThis may include requesting additional assessments for a complete evaluation / specialist consultation, etc.Protocol DeviationsIn collaboration with the CTL, retrain the site, to prevent future deviations / address any misunderstandings by the siteRetention issuesHelping to ensure that the site has followed up with patients in the event of lost to follow-up / all appropriate steps have been taken (in collaboration with the CTL) and that any protocol specific requirements have been metMissing assessmentsFor instance, in PNH studies, help to ensure that all LDH values that are not done / unable to be performed are rapidly chased to ensure a repeat is done as quickly as possible, in collaboration with the CRA / CTLFor other studies, may require help in working with site to obtain any key missing assessments (eg, images, PK samples, biomarker samples), in collaboration with the CRA / CTLLaboratory reference rangeIn collaboration with the CRA, ensure that the laboratory reference ranges are provided for local laboratory dataSite issuesDiscussion with the sites for any potential quality issues / concerns requiring physician to physician discussion (first line)The global medical director can be pulled in if the issue cannot be easily resolvedAttend CSTs, if possibleWeekly meetings with medical director (if possible) or weekly communication with medical director, at a minimumMay provide clinical assistance and feedback on PI interest in proposed studies at the local levelQualifications and Experience :MD required8+ years of industry clinical development experienceExpertise in Oncology, Hematology and CardiologyStrong understanding of clinical research landscape and implementation and conduct of clinical trials.Demonstrated ability to develop and maintain excellent working relationships with both internal stakeholders and study investigators and site staffDemonstrated ability to work well in cross functional and geographically diverse teamsAbility to communicate and work independently with scientific / technical personnel with excellent oral presentation skillsAbility to think critically, and demonstrated troubleshooting and problem-solving skillsExcellent initiative and judgment, and demonstrated ability to positively represent Regeneron in a compliant mannerCross cultural awareness and fluent in the local language of primary country assignment in addition to EnglishComputer skills including Excel, Word, and PowerPointA willingness to travel up to 65%, which may include local, regional and international travelValid drivers licensePosted : Thursday, January 9, 2025Job # 3555#J-18808-Ljbffr