Descripción de la oferta
Territory includes but not limited to: All of EU countries as needed ¿Tiene las cualificaciones y habilidades adecuadas para este trabajo? Descúbralo a continuación y pulse en "solicitar" para ser considerado.The Regional Medical Director (RMD) is an integral member of the metabolic/obesity clinical sciences group, who assists and extends Clinical Sciences across the metabolic portfolio on assigned studies at the regional level.Duties and Responsibilities:Site engagement and trainingo A cadence of touchpoints with sites on a regular basiso Meeting with sites and presenting at PSVs, SIVso Retraining as needed (e.g., due to amendments)Recruitment issueso Site identification/recruitment: Meeting with potential sites, in collaboration with CTL, to discuss the program/assess of their interesto Patient 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 siteso Helping 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/new This includes referencing and updating the FAQ, as applicable Medical Director should always be copied on the email correspondence for oversightAssisting with eligibility assessmentso Help perform eligibility checks or address urgent eligibility questions prior to randomizationAssisting with query closureo Helping site understand what is needed to close a medical query if there is a misunderstanding from the site regarding what is needed Feedback should also be provided to the study team if the query text could be improved for clarityo Helping 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 (i.e., the site has taken all reasonable steps to obtain the information, etc.) in collaboration with the CRA, if additional support is needed during escalation process Ensure that all questions have been answered/follow-up assessments have been done This may include requesting additional assessments for a complete evaluation/specialist consultation, etc.Protocol Deviationso In collaboration with the CTL, retrain the site, to prevent future deviations/address any misunderstandings by the siteRetention issueso Helping 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 assessmentso For 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/CTLo For 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 rangeo In collaboration with the CRA, ensure that the laboratory reference ranges are provided for local laboratory dataSite issueso Discussion 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 xohynlm at the local levelQualifications and Experience:MD PhD, or PharmD; MD strongly preferred8+ years of industry clinical development experienceExpertise in clinical trials and clinical developmentStrong understanding of the Metabolic/Obesity clinical research landscape and implementation and conduct of these clinical trialsDemonstrated 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 driver's license
