Regional Medical Director
2 days ago
Lugo
ppTerritory includes but not limited to: All of EU countries as needed. 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. /p h3Responsibilities /h3 ul liSite engagement and training ul liA cadence of touchpoints with sites on a regular basis /li liMeeting with sites and presenting at PSVs, SIVs /li liRetraining as needed (e.g., due to amendments) /li /ul /li liRecruitment issues ul liSite identification/recruitment: Meeting with potential sites, in collaboration with CTL, to discuss the program/assess their interest /li liPatient recruitment issues (ongoing oversight): Meeting with sites, in collaboration with CTL, to help understand the hurdles with recruitment at their site and trouble shooting /li liAnswering questions from sites /li liHelping 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 oversight /li /ul /li liAssisting with eligibility assessment ul liHelp perform eligibility checks or address urgent eligibility questions prior to randomization /li /ul /li liAssisting with query closure ul liHelping 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 clarity. /li liHelping 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. /li liEnsure that all questions have been answered/follow‑up assessments have been done. This may include requesting additional assessments for a complete evaluation or specialist consultation. /li /ul /li liProtocol deviations ul liIn collaboration with the CTL, retrain the site to prevent future deviations/address any misunderstandings by the site /li /ul /li liRetention issues ul liHelping 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 met /li /ul /li liMissing assessment ul liFor 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/CTL. /li liFor other studies, may require help in working with site to obtain any key missing assessments (e.g., images, PK samples, biomarker samples), in collaboration with the CRA/CTL. /li /ul /li liLaboratory reference range ul liIn collaboration with the CRA, ensure that the laboratory reference ranges are provided for local laboratory data /li /ul /li liSite issues ul liDiscussion with the sites for any potential quality issues/concerns requiring physician to physician discussion (first line). /li liThe global medical director can be pulled in if the issue cannot be easily resolved. /li liAttend CSTs, if possible. /li liWeekly meetings with medical director (if possible) or weekly communication with medical director, at a minimum. /li liMay provide clinical assistance and feedback on PI interest in proposed studies at the local level. /li /ul /li /ul h3Qualifications and Experience /h3 ul liMD, PhD, or PharmD; MD strongly preferred /li li8+ years of industry clinical development experience /li liExpertise in clinical trials and clinical development /li liStrong understanding of the Metabolic/Obesity clinical research landscape and implementation and conduct of these clinical trials /li liDemonstrated ability to develop and maintain excellent working relationships with both internal stakeholders and study investigators and site staff /li liDemonstrated ability to work well in cross functional and geographically diverse teams /li liAbility to communicate and work independently with scientific/technical personnel with excellent oral presentation skills /li liAbility to think critically, and demonstrated troubleshooting and problem‑solving skills /li liExcellent initiative and judgment, and demonstrated ability to positively represent Regeneron in a compliant manner /li liCross cultural awareness and fluent in the local language of primary country assignment in addition to English /li liComputer skills including Excel, Word, and PowerPoint /li liA willingness to travel up to 65%, which may include local, regional and international travel /li liValid driver’s license /li /ul pRegional Medical Director • Lugo, Kingdom Of Spain, ES /p /p #J-18808-Ljbffr
Concello de Abadin, 27737, Lugo
